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Trial record 1 of 1 for:    DV0002
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A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03766685
Recruitment Status : Completed
First Posted : December 6, 2018
Results First Posted : August 8, 2023
Last Update Posted : August 8, 2023
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Intervention Drug: Bimekizumab
Enrollment 172
Recruitment Details The study started to enroll study participants in December 2018 and concluded in September 2020. This study is a substudy to PS0014 (NCT03598790).
Pre-assignment Details Participant flow refers to Enrolled Set.
Arm/Group Title Bimekizumab-SS-1mL 320 mg Bimekizumab-AI-1mL 320 mg Bimekizumab-SS-2mL 320 mg Bimekizumab-AI-2mL 320 mg
Hide Arm/Group Description Participants self-injected bimekizumab (BKZ) 320 milligrams (mg) solution as a subcutaneous (sc) injection with bimekizumab-Safety Syringe-1 milliliter (mL) (BKZ-SS-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on every 4 weeks (Q4W) and every 8 weeks (Q8W) dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml prefilled syringe (PFS) at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants self-injected BKZ 320 mg solution as a sc injection with bimekizumab-Auto-Injector-1mL (BKZ-AI-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16.
Period Title: Overall Study
Started 66 68 19 19
Completed 65 61 19 18
Not Completed 1 7 0 1
Reason Not Completed
Lost to Follow-up             1             1             0             0
Adverse Event, not fatal             0             1             0             1
Withdrawal by Subject             0             2             0             0
Protocol Violation             0             1             0             0
Non-compliance             0             2             0             0
Arm/Group Title Bimekizumab-SS-1mL 320 mg (SS-s-1mL) Bimekizumab AI-1mL 320 mg (SS-a-1mL) Bimekizumab-SS-2mL 320 mg (SS-s-2mL) Bimekizumab-AI-2mL 320 mg (SS-a-2mL) Total Title
Hide Arm/Group Description Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the Safety Set (SS) for the 1mL safety syringe (s) device presentation (SS-s-1mL). Participants self-injected BKZ 320 mg solution as a sc injection with bimekizumab-Auto-Injector-1mL (BKZ-AI-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the SS for the 1mL auto-injector (a) device presentation (SS-a-1mL). Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL safety syringe (s) device presentation (SS-s-2mL). Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL auto-injector (a) device presentation (SS-a-2mL). [Not Specified]
Overall Number of Baseline Participants 65 68 19 19 171
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set (SS) consisted of all study participants who received at least 1 dose of bimekizumab by the indicated self-injection investigational device presentation (bimekizumab-SS-1mL SS [SS-s], bimekizumab-AI-1mL SS [SS-a], bimekizumab-SS-2mL SS [SS-s] and bimekizumab-AI-2mL SS [SS-a]). One study participant included in the Enrolled Set did not self-inject at any time during the study and is therefore not included in the Safety Set (SS-s-1mL).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 68 participants 19 participants 19 participants 171 participants
<=18 years
1
   1.5%
1
   1.5%
0
   0.0%
0
   0.0%
2
   1.2%
Between 18 and 65 years
57
  87.7%
59
  86.8%
16
  84.2%
18
  94.7%
150
  87.7%
>=65 years
7
  10.8%
8
  11.8%
3
  15.8%
1
   5.3%
19
  11.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 68 participants 19 participants 19 participants 171 participants
49.7  (13.4) 46.8  (14.0) 50.3  (15.8) 43.0  (12.4) 47.9  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 68 participants 19 participants 19 participants 171 participants
Female
22
  33.8%
19
  27.9%
9
  47.4%
9
  47.4%
59
  34.5%
Male
43
  66.2%
49
  72.1%
10
  52.6%
10
  52.6%
112
  65.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 68 participants 19 participants 19 participants 171 participants
Asian
2
   3.1%
2
   2.9%
1
   5.3%
2
  10.5%
7
   4.1%
Black or African American
2
   3.1%
2
   2.9%
1
   5.3%
0
   0.0%
5
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.5%
1
   5.3%
0
   0.0%
2
   1.2%
White
60
  92.3%
61
  89.7%
16
  84.2%
16
  84.2%
153
  89.5%
Other or Mixed
1
   1.5%
2
   2.9%
0
   0.0%
1
   5.3%
4
   2.3%
1.Primary Outcome
Title Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique
Hide Description Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set for device presentation bimekizumab-SS-1mL (FAS-s-1mL) and bimekizumab-AI-1mL (FAS-a-1mL) consisted of all study participants in the SS-s-1mL and SS-a-1mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection. Here, number of participants were included who were evaluable for the assessment.
Arm/Group Title Bimekizumab-SS-1mL 320 mg (FAS-s-1mL) Bimekizumab -AI-1mL 320 mg (FAS-a-1mL)
Hide Arm/Group Description:
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the Full Analysis Set (FAS) for the 1mL safety syringe (s) device presentation (FAS-s-1mL).
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the FAS for the 1mL auto-injector (a) device presentation (FAS-a-1mL).
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
100
(95.4 to 100)
100
(95.3 to 100)
2.Primary Outcome
Title Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique
Hide Description Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set for device presentation bimekizumab-SS-2mL (FAS-s-2mL) and bimekizumab-AI-2mL (FAS-a-2mL) consisted of all study participants in the SS-s-2mL and SS-a-2mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection.
Arm/Group Title Bimekizumab-SS-2mL 320 mg (FAS-s-2mL) Bimekizumab-AI-2mL 320 mg (FAS-a-2mL)
Hide Arm/Group Description:
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the FAS for the 2mL safety syringe (s) device presentation (FAS-s-2mL).
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the FAS for the 2mL auto-injector (a) device presentation (FAS-a-2mL).
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
100
(85.4 to 100)
94.7
(77.4 to 99.7)
3.Secondary Outcome
Title Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-1mL or the Bimekizumab-AI-1mL at Baseline, After Training in Self-injection Technique
Hide Description Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which showed that the IMP was delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).
Time Frame Baseline (the first self-injection visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set for device presentation bimekizumab-SS-1mL (FAS-s-1mL) and bimekizumab-AI-1mL (FAS-a-1mL) consisted of all study participants in the SS-s-1mL and SS-a-1mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection. Here, number of participants were included who were evaluable for the assessment.
Arm/Group Title Bimekizumab-SS-1mL 320 mg (FAS-s-1mL) Bimekizumab -AI-1mL 320 mg (FAS-a-1mL)
Hide Arm/Group Description:
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the FAS for the 1mL safety syringe (s) device presentation (FAS-s-1mL).
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the FAS for the 1mL auto-injector (a) device presentation (FAS-a-1mL).
Overall Number of Participants Analyzed 64 68
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
100
(95.4 to 100)
97.1
(91.0 to 99.5)
4.Secondary Outcome
Title Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Baseline, After Training in Self-injection Technique
Hide Description Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).
Time Frame Baseline (the first self-injection visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set for device presentation bimekizumab-SS-2mL (FAS-s-2mL) and bimekizumab-AI-2mL (FAS-a-2mL) consisted of all study participants in the SS-s-2mL and SS-a-2mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection.
Arm/Group Title Bimekizumab-SS-2mL 320 mg (FAS-s-2mL) Bimekizumab-AI-2mL 320 mg (FAS-a-2mL)
Hide Arm/Group Description:
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the FAS for the 2mL safety syringe (s) device presentation (FAS-s-2mL).
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the FAS for the 2mL auto-injector (a) device presentation (FAS-a-2mL).
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
100
(85.4 to 100)
100
(85.4 to 100)
Time Frame From Baseline up to Week 16
Adverse Event Reporting Description As pre-specified in protocol and SAP, this sub-study collected only specific Adverse Events (AEs) indicated as injection site reactions during selfinjection and investigational device-related AEs - i.e., adverse device effects (ADEs) and serious ADEs, which are reported.Treatment-Emergent (TE)ADEs were defined as AEs related to study device that have a start date on or following the first self-administration of study treatment through the final self-administration of study treatment plus 7 days.
 
Arm/Group Title Bimekizumab-SS-1mL 320 mg (SS-s-1mL) Bimekizumab AI-1mL 320 mg (SS-a-1mL) Bimekizumab-SS-2mL 320 mg (SS-s-2mL) Bimekizumab-AI-2mL 320 mg (SS-a-2mL)
Hide Arm/Group Description Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the SS for the 1mL safety syringe (s) device presentation (SS-s-1mL). Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the SS for the 1mL auto-injector (a) device presentation (SS-a-1mL). Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL safety syringe (s) device presentation (SS-s-2mL). Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL auto-injector (a) device presentation (SS-a-2mL).
All-Cause Mortality
Bimekizumab-SS-1mL 320 mg (SS-s-1mL) Bimekizumab AI-1mL 320 mg (SS-a-1mL) Bimekizumab-SS-2mL 320 mg (SS-s-2mL) Bimekizumab-AI-2mL 320 mg (SS-a-2mL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)      0/68 (0.00%)      0/19 (0.00%)      0/19 (0.00%)    
Hide Serious Adverse Events
Bimekizumab-SS-1mL 320 mg (SS-s-1mL) Bimekizumab AI-1mL 320 mg (SS-a-1mL) Bimekizumab-SS-2mL 320 mg (SS-s-2mL) Bimekizumab-AI-2mL 320 mg (SS-a-2mL)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/65 (0.00%)      0/68 (0.00%)      0/19 (0.00%)      0/19 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bimekizumab-SS-1mL 320 mg (SS-s-1mL) Bimekizumab AI-1mL 320 mg (SS-a-1mL) Bimekizumab-SS-2mL 320 mg (SS-s-2mL) Bimekizumab-AI-2mL 320 mg (SS-a-2mL)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/65 (0.00%)      0/68 (0.00%)      1/19 (5.26%)      1/19 (5.26%)    
General disorders         
Injection site reaction * 1  0/65 (0.00%)  0 0/68 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Injection site pain * 1  0/65 (0.00%)  0 0/68 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: 001 844 599 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT03766685    
Other Study ID Numbers: DV0002
First Submitted: December 5, 2018
First Posted: December 6, 2018
Results First Submitted: June 12, 2023
Results First Posted: August 8, 2023
Last Update Posted: August 8, 2023