A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine

• ClinicalTrials.gov Identifier: NCT02209181
• Recruitment Status: Completed
• First Posted: August 5, 2014
• Results First Posted: February 3, 2017
• Last Update Posted: February 3, 2017
• Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pain
• Interventions: Drug: JNJ-10450232 / Not yet marketed; Drug: acetaminophen / Tylenol
• Enrollment: 269

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Period Title: Overall Study
Started	67	67	69	66
Completed	66	66	68	66
Not Completed	1	1	1	0
Reason Not Completed
Adverse Event	1	0	1	0
Withdrawal by Subject	0	1	0	0

Baseline Characteristics

Arm/Group Title		Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg	Total
Arm/Group Description		Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally	Total of all reporting groups
Overall Number of Baseline Participants		67	67	69	66	269
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	67 participants	67 participants	69 participants	66 participants	269 participants
		19.2 (2.69)	19.0 (1.64)	19.0 (2.13)	19.3 (1.95)	19.1 (2.13)
Gender; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	67 participants	67 participants	69 participants	66 participants	269 participants
	Female	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Male	67 100.0%	67 100.0%	69 100.0%	66 100.0%	269 100.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
USA	Number Analyzed	67 participants	67 participants	69 participants	66 participants	269 participants
		67	67	69	66	269

Outcome Measures

1. Primary Outcome

Title	Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)
Description	Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain).
Time Frame	6 Hours

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	4.37 (1.783)	20.75 (1.783)	8.95 (1.757)	20.56 (1.797)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	16.38
	Confidence Interval	(2-Sided) 95%; 11.42 to 21.35
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.522
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.068
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	4.58
	Confidence Interval	(2-Sided) 95%; -0.35 to 9.51
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.503
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	16.20
	Confidence Interval	(2-Sided) 95%; 11.21 to 21.18
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.531
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-11.81
	Confidence Interval	(2-Sided) 95%; -16.73 to -6.88
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.503
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.941
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -5.17 to 4.80
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.531
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 15 minutes post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.13 (0.11)	0.25 (0.11)	0.06 (0.11)	0.21 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.448
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; -0.19 to 0.42
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.15
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.618
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95%; -0.38 to 0.22
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.15
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.621
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 95%; -0.23 to 0.38
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.15
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.207
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.49 to 0.11
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.15
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.794
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95%; -0.34 to 0.26
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.15
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 30 minutes post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.25 (0.19)	1.59 (0.19)	0.46 (0.18)	0.71 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.34
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.86
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.420
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95%; -0.30 to 0.72
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.083
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.46
	Confidence Interval	(2-Sided) 95%; -0.06 to 0.97
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.13
	Confidence Interval	(2-Sided) 95%; -1.64 to -0.62
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.88
	Confidence Interval	(2-Sided) 95%; -1.40 to -0.37
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.26
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 45 minutes post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.28 (0.24)	3.22 (0.24)	0.91 (0.23)	1.51 (0.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.93
	Confidence Interval	(2-Sided) 95%; 2.28 to 3.59
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.33
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.058
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95%; -0.02 to 1.29
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.33
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.23
	Confidence Interval	(2-Sided) 95%; 0.57 to 1.89
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.34
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.30
	Confidence Interval	(2-Sided) 95%; -2.96 to -1.65
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.33
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.71
	Confidence Interval	(2-Sided) 95%; -2.37 to -1.04
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.34
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 1 hour post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.25 (0.26)	3.98 (0.26)	1.03 (0.26)	2.19 (0.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.73
	Confidence Interval	(2-Sided) 95%; 3.01 to 4.46
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.37
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.035
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95%; 0.06 to 1.49
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.36
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.94
	Confidence Interval	(2-Sided) 95%; 1.21 to 2.67
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.37
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.96
	Confidence Interval	(2-Sided) 95%; -3.68 to -2.24
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.36
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.79
	Confidence Interval	(2-Sided) 95%; -2.52 to -1.07
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.37
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 1.5 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.37 (0.28)	4.35 (0.28)	1.23 (0.28)	2.85 (0.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.99
	Confidence Interval	(2-Sided) 95%; 3.21 to 4.77
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.39
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.028
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.09 to 1.64
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.39
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.48
	Confidence Interval	(2-Sided) 95%; 1.70 to 3.26
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.40
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.12
	Confidence Interval	(2-Sided) 95%; -3.90 to -2.35
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.39
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.51
	Confidence Interval	(2-Sided) 95%; -2.29 to -0.73
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.40
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 2 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.41 (0.31)	4.20 (0.31)	1.43 (0.31)	3.48 (0.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.78
	Confidence Interval	(2-Sided) 95%; 2.92 to 4.65
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.44
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.021
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.16 to 1.88
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.44
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.06
	Confidence Interval	(2-Sided) 95%; 2.19 to 3.93
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.44
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.77
	Confidence Interval	(2-Sided) 95%; -3.63 to -1.91
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.44
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.104
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.72
	Confidence Interval	(2-Sided) 95%; -1.59 to 0.15
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.44
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 3 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.71 (0.34)	3.84 (0.34)	1.69 (0.34)	3.86 (0.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.13
	Confidence Interval	(2-Sided) 95%; 2.18 to 4.07
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.48
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.041
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.04 to 1.92
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.48
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.14
	Confidence Interval	(2-Sided) 95%; 2.19 to 4.09
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.48
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.15
	Confidence Interval	(2-Sided) 95%; -3.09 to -1.21
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.48
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.973
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.93 to 0.97
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.48
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 4 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.91 (0.36)	3.78 (0.36)	1.79 (0.35)	4.17 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.87
	Confidence Interval	(2-Sided) 95%; 1.87 to 3.87
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.079
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; -0.10 to 1.88
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.50
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.27
	Confidence Interval	(2-Sided) 95%; 2.27 to 4.27
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.99
	Confidence Interval	(2-Sided) 95%; -2.98 to -1.00
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.50
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.440
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 95%; -0.61 to 1.40
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 5 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.01 (0.37)	3.56 (0.37)	1.82 (0.36)	4.14 (0.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.55
	Confidence Interval	(2-Sided) 95%; 1.52 to 3.57
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.118
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95%; -0.21 to 1.83
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.13
	Confidence Interval	(2-Sided) 95%; 2.10 to 4.16
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.73
	Confidence Interval	(2-Sided) 95%; -2.75 to -0.71
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.262
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 95%; -0.44 to 1.62
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.52
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 6 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.12 (0.37)	3.04 (0.37)	1.69 (0.37)	4.07 (0.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.92
	Confidence Interval	(2-Sided) 95%; 0.88 to 2.96
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.53
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.271
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 95%; -0.45 to 1.61
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.95
	Confidence Interval	(2-Sided) 95%; 1.91 to 3.99
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.53
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.011
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.34
	Confidence Interval	(2-Sided) 95%; -2.37 to -0.32
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.052
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; -0.01 to 2.07
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.53
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 7 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.13 (0.37)	2.38 (0.37)	1.66 (0.37)	3.94 (0.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.018
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.25
	Confidence Interval	(2-Sided) 95%; 0.21 to 2.29
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.53
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.310
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95%; -0.50 to 1.56
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.80
	Confidence Interval	(2-Sided) 95%; 1.76 to 3.85
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.53
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.172
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.72
	Confidence Interval	(2-Sided) 95%; -1.75 to 0.31
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.004
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.55
	Confidence Interval	(2-Sided) 95%; 0.51 to 2.60
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.53
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 8 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.15 (0.36)	1.99 (0.36)	1.51 (0.35)	4.00 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.102
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; -0.17 to 1.84
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.479
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.36
	Confidence Interval	(2-Sided) 95%; -0.64 to 1.35
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.85
	Confidence Interval	(2-Sided) 95%; 1.85 to 3.86
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.345
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.48
	Confidence Interval	(2-Sided) 95%; -1.47 to 0.52
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.01
	Confidence Interval	(2-Sided) 95%; 1.01 to 3.02
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 9 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.19 (0.36)	1.69 (0.36)	1.73 (0.36)	3.91 (0.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.338
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 95%; -0.52 to 1.51
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.299
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95%; -0.47 to 1.54
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.72
	Confidence Interval	(2-Sided) 95%; 1.70 to 3.73
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.942
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -0.97 to 1.04
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.22
	Confidence Interval	(2-Sided) 95%; 1.21 to 3.24
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.52
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 10 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.08 (0.36)	1.60 (0.36)	1.57 (0.36)	3.87 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.306
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 95%; -0.48 to 1.53
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.335
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 95%; -0.51 to 1.49
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.79
	Confidence Interval	(2-Sided) 95%; 1.78 to 3.80
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.946
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -1.03 to 0.97
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.27
	Confidence Interval	(2-Sided) 95%; 1.25 to 3.28
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 11 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.03 (0.36)	1.58 (0.36)	1.57 (0.36)	3.70 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.279
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.55
	Confidence Interval	(2-Sided) 95%; -0.45 to 1.56
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.292
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 95%; -0.46 to 1.53
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.67
	Confidence Interval	(2-Sided) 95%; 1.66 to 3.68
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.971
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95%; -1.02 to 0.98
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.11
	Confidence Interval	(2-Sided) 95%; 1.11 to 3.12
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 12 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.08 (0.36)	1.57 (0.36)	1.39 (0.35)	3.61 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.329
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.50
	Confidence Interval	(2-Sided) 95%; -0.50 to 1.50
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.531
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95%; -0.68 to 1.31
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.50
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.53
	Confidence Interval	(2-Sided) 95%; 1.53 to 3.54
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.722
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -1.17 to 0.81
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.50
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.04
	Confidence Interval	(2-Sided) 95%; 1.03 to 3.04
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.51
	Estimation Comments	[Not Specified]

18. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 16 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.93 (0.35)	1.37 (0.35)	1.08 (0.35)	3.43 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.380
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 95%; -0.54 to 1.42
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.50
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.767
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95%; -0.83 to 1.12
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.49
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.50
	Confidence Interval	(2-Sided) 95%; 1.52 to 3.49
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.50
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.557
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -1.27 to 0.68
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.49
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.06
	Confidence Interval	(2-Sided) 95%; 1.08 to 3.05
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.50
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose
Description	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Time Frame	Baseline to 24 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.15 (0.39)	1.41 (0.39)	1.29 (0.38)	3.47 (0.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.640
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.26
	Confidence Interval	(2-Sided) 95%; -0.83 to 1.35
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.55
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.798
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; -0.94 to 1.22
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.55
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.32
	Confidence Interval	(2-Sided) 95%; 1.23 to 3.42
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.55
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.829
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.12
	Confidence Interval	(2-Sided) 95%; -1.20 to 0.96
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.55
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.06
	Confidence Interval	(2-Sided) 95%; 0.97 to 3.16
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.55
	Estimation Comments	[Not Specified]

20. Secondary Outcome

Title	Pain Relief (PAR) Scores at 15 Minutes Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	15 minutes post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.27 (0.11)	0.52 (0.11)	0.33 (0.11)	0.38 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.117
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 95%; -0.06 to 0.57
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.16
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.687
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; -0.25 to 0.38
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.16
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.497
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; -0.21 to 0.43
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.16
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.239
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.51 to 0.13
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.16
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.376
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95%; -0.46 to 0.18
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.16
	Estimation Comments	[Not Specified]

21. Secondary Outcome

Title	Pain Relief (PAR) Scores at 30 Minutes Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	30 minutes post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.60 (0.23)	2.38 (0.23)	0.90 (0.23)	1.03 (0.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.78
	Confidence Interval	(2-Sided) 95%; 1.14 to 2.42
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.32
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.350
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 95%; -0.33 to 0.94
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.32
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.183
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.43
	Confidence Interval	(2-Sided) 95%; -0.21 to 1.08
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.33
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.48
	Confidence Interval	(2-Sided) 95%; -2.11 to -0.84
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.32
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.34
	Confidence Interval	(2-Sided) 95%; -1.98 to -0.70
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.33
	Estimation Comments	[Not Specified]

22. Secondary Outcome

Title	Pain Relief (PAR) Scores at 45 Minutes Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	45 minutes post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.64 (0.30)	4.42 (0.30)	1.52 (0.30)	2.11 (0.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.78
	Confidence Interval	(2-Sided) 95%; 2.94 to 4.61
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.42
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.037
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.05 to 1.71
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.42
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.47
	Confidence Interval	(2-Sided) 95%; 0.63 to 2.30
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.43
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.90
	Confidence Interval	(2-Sided) 95%; -3.73 to -2.07
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.42
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.31
	Confidence Interval	(2-Sided) 95%; -3.15 to -1.47
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.43
	Estimation Comments	[Not Specified]

23. Secondary Outcome

Title	Pain Relief (PAR) Scores at 1 Hour Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	1 hour post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.84 (0.33)	5.18 (0.33)	1.68 (0.32)	3.09 (0.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	4.34
	Confidence Interval	(2-Sided) 95%; 3.43 to 5.25
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.46
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.067
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; -0.06 to 1.75
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.46
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.26
	Confidence Interval	(2-Sided) 95%; 1.34 to 3.17
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.46
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.49
	Confidence Interval	(2-Sided) 95%; -4.40 to -2.59
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.46
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.08
	Confidence Interval	(2-Sided) 95%; -3.00 to -1.17
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.46
	Estimation Comments	[Not Specified]

24. Secondary Outcome

Title	Pain Relief (PAR) Scores at 1.5 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	1.5 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.01 (0.35)	5.88 (0.35)	2.13 (0.34)	3.97 (0.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	4.87
	Confidence Interval	(2-Sided) 95%; 3.90 to 5.84
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.49
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.023
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.16 to 2.09
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.49
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.96
	Confidence Interval	(2-Sided) 95%; 1.98 to 3.93
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.50
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.75
	Confidence Interval	(2-Sided) 95%; -4.71 to -2.78
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.49
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.91
	Confidence Interval	(2-Sided) 95%; -2.89 to -0.94
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.50
	Estimation Comments	[Not Specified]

25. Secondary Outcome

Title	Pain Relief (PAR) Scores at 2 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	2 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.17 (0.38)	5.88 (0.38)	2.53 (0.38)	4.90 (0.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	4.71
	Confidence Interval	(2-Sided) 95%; 3.64 to 5.78
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.54
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.012
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.36
	Confidence Interval	(2-Sided) 95%; 0.30 to 2.42
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.54
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.73
	Confidence Interval	(2-Sided) 95%; 2.66 to 4.81
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.54
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.35
	Confidence Interval	(2-Sided) 95%; -4.41 to -2.29
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.54
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.074
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.98
	Confidence Interval	(2-Sided) 95%; -2.05 to 0.09
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.54
	Estimation Comments	[Not Specified]

26. Secondary Outcome

Title	Pain Relief (PAR) Scores at 3 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	3 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.59 (0.42)	5.39 (0.42)	2.90 (0.41)	5.40 (0.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.80
	Confidence Interval	(2-Sided) 95%; 2.63 to 4.97
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.59
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.026
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95%; 0.16 to 2.48
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.59
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.82
	Confidence Interval	(2-Sided) 95%; 2.64 to 4.99
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.60
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.48
	Confidence Interval	(2-Sided) 95%; -3.64 to -1.32
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.59
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.978
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -1.16 to 1.19
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.60
	Estimation Comments	[Not Specified]

27. Secondary Outcome

Title	Pain Relief (PAR) Scores at 4 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	4 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	1.92 (0.44)	5.31 (0.44)	2.99 (0.43)	5.83 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.40
	Confidence Interval	(2-Sided) 95%; 2.18 to 4.62
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.62
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.081
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; -0.13 to 2.28
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.61
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.91
	Confidence Interval	(2-Sided) 95%; 2.69 to 5.14
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.62
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.32
	Confidence Interval	(2-Sided) 95%; -3.53 to -1.11
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.61
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.407
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 95%; -0.71 to 1.74
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.62
	Estimation Comments	[Not Specified]

28. Secondary Outcome

Title	Pain Relief (PAR) Scores at 5 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	5 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	2.17 (0.45)	5.00 (0.45)	3.05 (0.45)	5.77 (0.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.83
	Confidence Interval	(2-Sided) 95%; 1.56 to 4.10
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.170
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; -0.38 to 2.14
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.60
	Confidence Interval	(2-Sided) 95%; 2.33 to 4.87
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.95
	Confidence Interval	(2-Sided) 95%; -3.21 to -0.69
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.235
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; -0.50 to 2.04
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

29. Secondary Outcome

Title	Pain Relief (PAR) Scores at 6 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	6 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	2.32 (0.46)	4.42 (0.46)	2.92 (0.45)	5.68 (0.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.10
	Confidence Interval	(2-Sided) 95%; 0.82 to 3.39
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.355
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; -0.68 to 1.87
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.36
	Confidence Interval	(2-Sided) 95%; 2.07 to 4.65
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.021
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.50
	Confidence Interval	(2-Sided) 95%; -2.78 to -0.23
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.056
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.26
	Confidence Interval	(2-Sided) 95%; -0.03 to 2.55
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

30. Secondary Outcome

Title	Pain Relief (PAR) Scores at 7 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	7 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	2.41 (0.46)	3.62 (0.47)	2.80 (0.46)	5.57 (0.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.067
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.21
	Confidence Interval	(2-Sided) 95%; -0.09 to 2.50
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.66
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.547
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 95%; -0.89 to 1.68
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.16
	Confidence Interval	(2-Sided) 95%; 1.86 to 4.46
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.66
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.214
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.81
	Confidence Interval	(2-Sided) 95%; -2.10 to 0.47
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.96
	Confidence Interval	(2-Sided) 95%; 0.66 to 3.26
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.66
	Estimation Comments	[Not Specified]

31. Secondary Outcome

Title	Pain Relief (PAR) Scores at 8 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	8 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	2.41 (0.45)	3.10 (0.45)	2.63 (0.44)	5.62 (0.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.281
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 95%; -0.57 to 1.95
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.729
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; -1.03 to 1.47
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.63
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.21
	Confidence Interval	(2-Sided) 95%; 1.95 to 4.47
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.459
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95%; -1.72 to 0.78
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.63
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.52
	Confidence Interval	(2-Sided) 95%; 1.26 to 3.78
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

32. Secondary Outcome

Title	Pain Relief (PAR) Scores at 9 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	9 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	2.46 (0.46)	2.73 (0.46)	2.98 (0.45)	5.50 (0.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.674
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.27
	Confidence Interval	(2-Sided) 95%; -1.00 to 1.55
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.417
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 95%; -0.74 to 1.79
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.05
	Confidence Interval	(2-Sided) 95%; 1.77 to 4.33
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.698
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 95%; -1.02 to 1.52
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.77
	Confidence Interval	(2-Sided) 95%; 1.49 to 4.05
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

33. Secondary Outcome

Title	Pain Relief (PAR) Scores at 10 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	10 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	2.28 (0.46)	2.67 (0.46)	2.81 (0.45)	5.40 (0.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.541
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 95%; -0.87 to 1.66
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.409
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95%; -0.73 to 1.79
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.12
	Confidence Interval	(2-Sided) 95%; 1.85 to 4.39
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.834
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95%; -1.12 to 1.39
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.73
	Confidence Interval	(2-Sided) 95%; 1.45 to 4.00
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

34. Secondary Outcome

Title	Pain Relief (PAR) Scores at 11 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	11 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	2.26 (0.45)	2.63 (0.45)	2.75 (0.45)	5.25 (0.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.573
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.36
	Confidence Interval	(2-Sided) 95%; -0.90 to 1.63
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.448
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 95%; -0.77 to 1.74
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.98
	Confidence Interval	(2-Sided) 95%; 1.71 to 4.25
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.848
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; -1.13 to 1.38
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.62
	Confidence Interval	(2-Sided) 95%; 1.35 to 3.89
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

35. Secondary Outcome

Title	Pain Relief (PAR) Scores at 12 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	12 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	2.34 (0.46)	2.57 (0.46)	2.53 (0.45)	5.16 (0.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.720
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.23
	Confidence Interval	(2-Sided) 95%; -1.04 to 1.50
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.763
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 95%; -1.07 to 1.45
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.82
	Confidence Interval	(2-Sided) 95%; 1.55 to 4.09
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.952
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95%; -1.30 to 1.22
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.59
	Confidence Interval	(2-Sided) 95%; 1.31 to 3.86
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.65
	Estimation Comments	[Not Specified]

36. Secondary Outcome

Title	Pain Relief (PAR) Scores at 16 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	16 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	2.09 (0.45)	2.23 (0.45)	2.07 (0.44)	4.96 (0.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.821
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; -1.10 to 1.39
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.63
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.978
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95%; -1.25 to 1.22
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.63
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.88
	Confidence Interval	(2-Sided) 95%; 1.63 to 4.13
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.63
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.799
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 95%; -1.39 to 1.07
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.63
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.73
	Confidence Interval	(2-Sided) 95%; 1.49 to 3.98
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.63
	Estimation Comments	[Not Specified]

37. Secondary Outcome

Title	Pain Relief (PAR) Scores at 24 Hours Post Dose
Description	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame	24 hours post dose

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	2.44 (0.49)	2.20 (0.50)	2.33 (0.49)	4.96 (0.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.726
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -1.62 to 1.13
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.70
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.869
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -1.48 to 1.25
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.69
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.52
	Confidence Interval	(2-Sided) 95%; 1.13 to 3.90
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.70
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.851
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95%; -1.24 to 1.50
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.69
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.76
	Confidence Interval	(2-Sided) 95%; 1.38 to 4.15
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.70
	Estimation Comments	[Not Specified]

38. Secondary Outcome

Title	Duration of Pain Relief After Dosing (Time to Rescue Medication)
Description	Time (minutes) to rescue medication was measured as the elapsed time from when the investigational product was given until the time rescue medication was given.
Time Frame	Completed at time of the first rescue medication (hours post dose), estimated up through Day 2

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Median (95% Confidence Interval); Unit of Measure: minutes
	109.0; (97.0 to 189.0)	468.5; (370.0 to 607.0)	129.0; (100.0 to 725.0)	NA [1]; (768.0 to NA)

[1]

Median and upper limit of the confidence interval were not estimable since less than 50% of the subjects treated with JNJ-10450232 1000 mg used rescue medication.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.042
	Comments	The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.
	Method	Log Rank
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.779
	Comments	The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.
	Method	Log Rank
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.
	Method	Log Rank
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.196
	Comments	The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.
	Method	Log Rank
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.
	Method	Log Rank
	Comments	[Not Specified]

39. Secondary Outcome

Title	Subject Global Evaluation
Description	How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent).
Time Frame	Completed at hour 12 or at time of the first rescue medication (hours post dose).

Outcome Measure Data

Analysis Population Description

Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description:	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Number of Participants Analyzed	67	67	69	66
Measure Type: Number; Unit of Measure: percentage of participants
Poor (0)	62.7	12.1	55.1	28.8
Fair (1)	14.9	9.1	4.3	6.1
Good (2)	11.9	30.3	21.7	22.7
Very Good (3)	10.4	42.4	15.9	30.3
Excellent (4)	0.0	6.1	2.9	12.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Acetaminophen 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; 1.1 to 1.9
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.21
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.077
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -0.0 to 0.8
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.21
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 0.8 to 1.6
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.21
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 250 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -1.6 to -0.7
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.21
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen 1000 mg, JNJ-10450232 1000 mg
	Comments	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.148
	Comments	The significance threshold level was 0.05 (two-sided).
	Method	ANOVA
	Comments	Treatment and baseline pain categorical score were factors.
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -0.7 to 0.1
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.21
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Within 7 days after dental surgery, +30 days for serious adverse events.
Adverse Event Reporting Description	Adverse events (AEs) were systematically collected during the study and during the adverse event follow-up telephone interview within 7 days after dental surgery. Serious AEs were reported through 30 days after product use. Spontaneously reported AEs collected outside of the regularly scheduled telephone interviews were also recorded. Any clinically important abnormalities or causally-related AEs events persisting were followed until resolution or until reaching a clinically stable endpoint.
Arm/Group Title	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
Arm/Group Description	Three placebo capsules taken orally	Two encapsulated 500 mg tablets and one placebo capsule taken orally	One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
All-Cause Mortality
	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--
Serious Adverse Events
	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/67 (0.00%)	0/67 (0.00%)	0/69 (0.00%)	0/66 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/67 (4.48%)	5/67 (7.46%)	3/69 (4.35%)	5/66 (7.58%)
Investigations
Blood Bilirubin Increased † 1	3/67 (4.48%)	5/67 (7.46%)	3/69 (4.35%)	5/66 (7.58%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 16.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Joseph Aquilina, MD, Senior Director, Clinical Research
• Organization: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
• Phone: (215) 273-8025
• EMail: JAquilin@its.jnj.com

• Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. )
• ClinicalTrials.gov Identifier: NCT02209181
• Other Study ID Numbers: CO-131230135611-CTPA
• First Submitted: July 22, 2014
• First Posted: August 5, 2014
• Results First Submitted: October 12, 2016
• Results First Posted: February 3, 2017
• Last Update Posted: February 3, 2017