Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant (CLEAR Serenity)

• ClinicalTrials.gov Identifier: NCT02988115
• Recruitment Status: Completed
• First Posted: December 9, 2016
• Results First Posted: April 3, 2020
• Last Update Posted: April 3, 2020
• Sponsor: Esperion Therapeutics, Inc.
• Information provided by (Responsible Party): Esperion Therapeutics, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Hypercholesterolemia; Atherosclerotic Cardiovascular Disease; Statin Adverse Reaction
• Interventions: Drug: bempedoic acid; Other: placebo
• Enrollment: 345

Participant Flow

Recruitment Details	602 participants were screened; out of 602, 345 participants were randomized. 76 participants discontinued investigational medicinal product (IMP), and 18 participants withdrew from the study.
Pre-assignment Details

Arm/Group Title	Bempedoic Acid	Placebo
Arm/Group Description	Participants received a bempedoic acid 180 milligram (mg) tablet taken orally once a day.	Participants received matching oral placebo once a day.
Period Title: Overall Study
Started	234	111
Completed	220	107
Not Completed	14	4
Reason Not Completed
Adverse Event	6	1
Sponsor Decision	5	2
Withdrawal by Subject	1	1
Withdrawn by Mistake	1	0
Lost to Follow-up	1	0

Baseline Characteristics

Arm/Group Title		Bempedoic Acid	Placebo	Total
Arm/Group Description		Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.	Participants received matching oral placebo once a day.	Total of all reporting groups
Overall Number of Baseline Participants		234	111	345
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	234 participants	111 participants	345 participants
		65.2 (9.66)	65.1 (9.21)	65.2 (9.50)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	234 participants	111 participants	345 participants
	Female	133 56.8%	61 55.0%	194 56.2%
	Male	101 43.2%	50 45.0%	151 43.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	234 participants	111 participants	345 participants
	American Indian or Alaska Native	1 0.4%	0 0.0%	1 0.3%
	Asian	6 2.6%	2 1.8%	8 2.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	2 1.8%	2 0.6%
	Black or African American	16 6.8%	10 9.0%	26 7.5%
	White	211 90.2%	96 86.5%	307 89.0%
	More than one race	0 0.0%	1 0.9%	1 0.3%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Baseline LCL-C, Non-HDL-C, TC, HDL-C, and TG Values [1]; Mean (Standard Deviation); Unit of measure: Milligrams per deciliter (mg/dL)
LDL-C	Number Analyzed	234 participants	111 participants	345 participants
		158.48 (40.387)	155.58 (38.812)	157.55 (39.854)
Non-HDL-C	Number Analyzed	234 participants	111 participants	345 participants
		193.49 (45.101)	190.69 (43.781)	192.59 (44.637)
TC	Number Analyzed	234 participants	111 participants	345 participants
		245.66 (47.252)	241.09 (44.289)	244.19 (46.304)
HDL-C	Number Analyzed	234 participants	111 participants	345 participants
		52.17 (14.535)	50.41 (14.384)	51.60 (14.489)
TG	Number Analyzed	234 participants	111 participants	345 participants
		178.96 (87.522)	186.62 (96.203)	181.42 (90.336)
		[1] Measure Description: Baseline is defined as the mean of the last two non-missing values on or prior to Day 1. LDL-C, low-density lipoprotein cholesterol; Non-HDL-C, non-high-density lipoprotein cholesterol; TC, total cholesterol; HDL-C, high-density lipoprotein cholesterol; and TG, triglycerides.
Baseline Apolipoprotein B (apoB) [1] [2]; Mean (Standard Deviation); Unit of measure: mg/dL
	Number Analyzed	231 participants	107 participants	338 participants
		141.0 (31.64)	141.9 (30.44)	141.3 (31.22)
		[1] Measure Description: Baseline is defined as the last non-missing value on or prior to Day 1.; [2] Measure Analysis Population Description: Only those participants with available data were analyzed.
Baseline High-Sensitivity C-Reactive Protein (hsCRP) Values [1] [2]; Median (Full Range); Unit of measure: Milligrams per liter (mg/L)
	Number Analyzed	231 participants	106 participants	337 participants
		2.920; (1.340 to 5.290)	2.780; (1.210 to 5.150)	2.900; (1.290 to 5.150)
		[1] Measure Description: Baseline is defined as the last non-missing value on or prior to Day 1.; [2] Measure Analysis Population Description: Only those participants with available data were analyzed.

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Description	PCFB was calculated as the ([post-Baseline (BL) value minus the BL value] divided by the BL value ) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available, that single value was used as BL. PCFB in LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment group and stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing lipid data at Week 12 who were no longer taking study treatment, missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking study treatment, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.
Time Frame	Baseline; Week 12

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS), also known as the intention-to-treat (ITT) set of participants, is defined as all randomized participants. Participants were included in their randomized treatment group, regardless of the treatment they actually received. Only those participants with available data were analyzed.

Arm/Group Title	Bempedoic Acid	Placebo
Arm/Group Description:	Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.	Participants received matching oral placebo once a day.
Overall Number of Participants Analyzed	224	107
Least Squares Mean (Standard Error); Unit of Measure: percent change
	-22.58 (1.290)	-1.17 (1.421)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bempedoic Acid, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least squares means difference
	Estimated Value	-21.41
	Confidence Interval	(2-Sided) 95%; -25.132 to -17.697
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.897
	Estimation Comments	bempedoic acid (BA) therapy minus placebo

2. Secondary Outcome

Title	Percent Change From Baseline in LDL-C at Week 24
Description	PCFB was calculated as the ([post-BL value minus the BL value] divided by the BL value ) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available then that single value was used as BL. PCFB in LDL-C was analyzed using ANCOVA, with treatment group and stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing lipid data at Week 12 who were no longer taking study treatment, missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking study treatment, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.
Time Frame	Baseline; Week 24

Outcome Measure Data

Analysis Population Description

FAS. Only those participants with available data were analyzed.

Arm/Group Title	Bempedoic Acid	Placebo
Arm/Group Description:	Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.	Participants received matching oral placebo once a day.
Overall Number of Participants Analyzed	217	106
Least Squares Mean (Standard Error); Unit of Measure: percent change
	-21.17 (1.411)	-2.26 (1.552)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bempedoic Acid, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least squares means difference
	Estimated Value	-18.91
	Confidence Interval	(2-Sided) 95%; -22.951 to -14.865
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.063
	Estimation Comments	BA therapy minus placebo

3. Secondary Outcome

Title	Percent Change From Baseline in the Lipid Profile at Week 12
Description	PCFB was calculated as: ([post-BL value minus the BL value] divided by the BL value) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available, that single value was used as BL. apoB and TC BL were defined as the last non-missing value on/prior to Day 1. PCFB was analyzed using ANCOVA, with treatment and group stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing data at Week 12 who were no longer taking study treatment (ST), missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking ST, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.
Time Frame	Baseline; Week 12

Outcome Measure Data

Analysis Population Description

FAS. Only those participants with available data were analyzed.

Arm/Group Title		Bempedoic Acid	Placebo
Arm/Group Description:		Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.	Participants received matching oral placebo once a day.
Overall Number of Participants Analyzed		224	107
Least Squares Mean (Standard Error); Unit of Measure: percent change
non-HDL-C	Number Analyzed	224 participants	107 participants
		-18.08 (1.114)	-0.14 (1.169)
TC	Number Analyzed	224 participants	107 participants
		-15.37 (0.879)	-0.61 (0.961)
apoB	Number Analyzed	218 participants	104 participants
		-14.65 (1.080)	0.32 (1.177)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bempedoic Acid, Placebo
	Comments	non-HDL-C
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least squares means difference
	Estimated Value	-17.94
	Confidence Interval	(2-Sided) 95%; -21.070 to -14.811
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.597
	Estimation Comments	BA therapy minus placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Bempedoic Acid, Placebo
	Comments	TC
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least squares means difference
	Estimated Value	-14.76
	Confidence Interval	(2-Sided) 95%; -17.283 to -12.239
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.287
	Estimation Comments	BA therapy minus placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Bempedoic Acid, Placebo
	Comments	apoB
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least squares means difference
	Estimated Value	-14.96
	Confidence Interval	(2-Sided) 95%; -18.062 to -11.866
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.581
	Estimation Comments	BA therapy minus placebo

4. Secondary Outcome

Title	Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 12
Description	Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline for hsCRP is defined as the last non-missing value on or prior to Day 1. Percent change from Baseline in hsCRP, non-parametric (Wilcoxon rank-sum test) analysis with Hodges-Lehmann estimates and confidence interval was performed.
Time Frame	Baseline; Week 12

Outcome Measure Data

Analysis Population Description

FAS. Only those participants with available data were analyzed.

Arm/Group Title	Bempedoic Acid	Placebo
Arm/Group Description:	Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.	Participants received matching oral placebo once a day.
Overall Number of Participants Analyzed	218	103
Median (Inter-Quartile Range); Unit of Measure: percent change
	-25.37; (-52.75 to 10.78)	2.67; (-31.07 to 38.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bempedoic Acid, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Wilcoxon rank sum test
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median treatment difference
	Estimated Value	-24.290
	Confidence Interval	(2-Sided) 95%; -35.888 to -12.712
	Parameter Dispersion	Type: Standard Error of the Mean; Value: -24.300
	Estimation Comments	BA therapy minus placebo

5. Secondary Outcome

Title	Absolute Change From Baseline in LDL-C at Week 12 and Week 24
Description	Change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the mean of the last two non-missing values on or prior to Day 1.
Time Frame	Baseline; Week 12; Week 24

Outcome Measure Data

Analysis Population Description

FAS. Only those participants with available data were analyzed.

Arm/Group Title		Bempedoic Acid	Placebo
Arm/Group Description:		Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.	Participants received matching oral placebo once a day.
Overall Number of Participants Analyzed		224	107
Mean (Standard Deviation); Unit of Measure: mg/dL
Week 12	Number Analyzed	224 participants	107 participants
		-39.3 (33.37)	-3.1 (23.66)
Week 24	Number Analyzed	217 participants	106 participants
		-37.0 (35.27)	-5.1 (26.50)

Adverse Events

Time Frame	Up to 24 weeks plus 30 days
Adverse Event Reporting Description	Treatment-emergent adverse events (TEAEs), defined as those events that began or worsened after the first dose of IMP until 30 days after the last dose of IMP, were reported for the Safety Population. The Safety Population is defined as all randomized participants who received at least 1 dose of double-blind study medication.
Arm/Group Title	Bempedoic Acid	Placebo
Arm/Group Description	Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.	Participants received matching oral placebo once a day.
All-Cause Mortality
	Bempedoic Acid	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/234 (0.00%)	0/111 (0.00%)
Serious Adverse Events
	Bempedoic Acid	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	14/234 (5.98%)	4/111 (3.60%)
Blood and lymphatic system disorders
Cerebrovascular accident † 1	1/234 (0.43%)	0/111 (0.00%)
Ischaemic stroke † 1	1/234 (0.43%)	0/111 (0.00%)
Myeloproliferative neoplasm † 1	1/234 (0.43%)	0/111 (0.00%)
Escherichia sepsis † 1	0/234 (0.00%)	1/111 (0.90%)
Cardiac disorders
Angina unstable † 1	3/234 (1.28%)	0/111 (0.00%)
Coronary artery disease † 1	3/234 (1.28%)	0/111 (0.00%)
Angina pectoris † 1	1/234 (0.43%)	0/111 (0.00%)
Myocardial infarction † 1	1/234 (0.43%)	0/111 (0.00%)
Aortic aneurysm † 1	0/234 (0.00%)	1/111 (0.90%)
Eye disorders
Corneal lesion † 1	1/234 (0.43%)	0/111 (0.00%)
Gastrointestinal disorders
Colitis † 1	1/234 (0.43%)	0/111 (0.00%)
General disorders
Non-cardiac chest pain † 1	1/234 (0.43%)	0/111 (0.00%)
Nervous system disorders
Hypoxic-ischaemic encephalopathy † 1	1/234 (0.43%)	0/111 (0.00%)
Seizure † 1	1/234 (0.43%)	0/111 (0.00%)
Traumatic intracranial haemorrhage † 1	0/234 (0.00%)	1/111 (0.90%)
Renal and urinary disorders
Urinary tract infection † 1	1/234 (0.43%)	0/111 (0.00%)
Acute kidney injury † 1	0/234 (0.00%)	1/111 (0.90%)
Escherichia pyelonephritis † 1	0/234 (0.00%)	1/111 (0.90%)
Nephrolithiasis † 1	0/234 (0.00%)	1/111 (0.90%)
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection bacterial † 1	1/234 (0.43%)	0/111 (0.00%)
Pneumonia aspiration † 1	1/234 (0.43%)	0/111 (0.00%)
Respiratory failure † 1	1/234 (0.43%)	0/111 (0.00%)
Skin and subcutaneous tissue disorders
Staphylococcal infection † 1	1/234 (0.43%)	0/111 (0.00%)
1 Term from vocabulary, MedDRA (20.1); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Bempedoic Acid	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	88/234 (37.61%)	45/111 (40.54%)
Gastrointestinal disorders
Dyspepsia † 1	5/234 (2.14%)	0/111 (0.00%)
Nausea † 1	4/234 (1.71%)	3/111 (2.70%)
General disorders
Fatigue † 1	8/234 (3.42%)	7/111 (6.31%)
Infections and infestations
Bronchitis † 1	6/234 (2.56%)	6/111 (5.41%)
Nasopharyngitis † 1	3/234 (1.28%)	5/111 (4.50%)
Upper respiratory tract infection † 1	2/234 (0.85%)	3/111 (2.70%)
Urinary tract infection † 1	7/234 (2.99%)	9/111 (8.11%)
Investigations
Blood creatine phosphokinase increased † 1	5/234 (2.14%)	0/111 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	14/234 (5.98%)	5/111 (4.50%)
Back pain † 1	7/234 (2.99%)	4/111 (3.60%)
Muscle spasms † 1	10/234 (4.27%)	5/111 (4.50%)
Myalgia † 1	11/234 (4.70%)	8/111 (7.21%)
Osteoarthritis † 1	1/234 (0.43%)	3/111 (2.70%)
Pain in extremity † 1	13/234 (5.56%)	4/111 (3.60%)
Nervous system disorders
Dizziness † 1	7/234 (2.99%)	0/111 (0.00%)
Headache † 1	4/234 (1.71%)	3/111 (2.70%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	4/234 (1.71%)	3/111 (2.70%)
Vascular disorders
Hypertension † 1	10/234 (4.27%)	2/111 (1.80%)
1 Term from vocabulary, MedDRA (20.1); † Indicates events were collected by systematic assessment

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.

If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that publication be withheld.

Results Point of Contact

• Name/Title: Medical Director
• Organization: Esperion Therapeutics, Inc.
• Phone: 1-833-377-7633
• EMail: medinfo@esperion.com

Publications:

Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.

Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.

Eckel RH. Approach to the patient who is intolerant of statin therapy. J Clin Endocrinol Metab. 2010 May;95(5):2015-22. doi: 10.1210/jc.2009-2689.

Ridker PM, Cannon CP, Morrow D, Rifai N, Rose LM, McCabe CH, Pfeffer MA, Braunwald E; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) Investigators. C-reactive protein levels and outcomes after statin therapy. N Engl J Med. 2005 Jan 6;352(1):20-8. doi: 10.1056/NEJMoa042378.

Robinson JG, Stone NJ. The 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk: a new paradigm supported by more evidence. Eur Heart J. 2015 Aug 14;36(31):2110-2118. doi: 10.1093/eurheartj/ehv182. Epub 2015 May 20.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ballantyne CM, Bays HE, Louie MJ, Smart J, Zhang Y, Ray KK. Factors Associated With Enhanced Low-Density Lipoprotein Cholesterol Lowering With Bempedoic Acid. J Am Heart Assoc. 2022 Aug 2;11(15):e024531. doi: 10.1161/JAHA.121.024531. Epub 2022 Aug 2.

Banach M, Duell PB, Gotto AM Jr, Laufs U, Leiter LA, Mancini GBJ, Ray KK, Flaim J, Ye Z, Catapano AL. Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia. JAMA Cardiol. 2020 Oct 1;5(10):1124-1135. doi: 10.1001/jamacardio.2020.2314.

Laufs U, Banach M, Mancini GBJ, Gaudet D, Bloedon LT, Sterling LR, Kelly S, Stroes ESG. Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019 Apr 2;8(7):e011662. doi: 10.1161/JAHA.118.011662.

• Responsible Party: Esperion Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02988115
• Other Study ID Numbers: 1002-046
• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Results First Submitted: March 20, 2020
• Results First Posted: April 3, 2020
• Last Update Posted: April 3, 2020