Trial Outcomes & Findings for Safety and Dose-Finding Study of DTX401 (AAV8G6PC) in Adults With Glycogen Storage Disease Type Ia (GSDIa) (NCT NCT03517085)

Last Updated: 2022-11-18

Results Overview

An AE is defined as any untoward medical occurrence, regardless of its causal relationship to study product. An SAE is defined as any event that: results in death; is immediately life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; or an important medical event, in the opinion of the investigator. The relationship to study drug was categorized as unrelated, possible, probable or definite. A DLT is defined as any AE/SAE ≥ Grade 3 that is considered by the Investigator and/or Sponsor to be related to DTX401, based on the Nation Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 or later version. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

AEs Prior to Dosing: From signing the informed consent form (ICF) to first dose of study drug. TEAEs: From first dose of study drug through the End of Study (EOS)/Early Withdrawal visit (up to Week 52) plus 30 days.

Results posted on

2022-11-18

Participant Flow

Eligible participants were enrolled sequentially into 4 cohorts of 3 participants each and received a single intravenous (IV) infusion of DTX401, with steroids (prednisone/prednisolone) to manage alanine aminotransferase (ALT) elevation.

Participant milestones

Participant milestones
Measure	DTX401 Cohort 1 DTX401 Dose 1 (2.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 2 DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 3 DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with an optimized reactive steroid regimen (7 weeks, at a starting dose of 60 mg/day, after ALT elevation)	DTX401 Cohort 4 DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a prophylactic steroid regimen (8 weeks, at a starting dose of 60 mg/day, starting on Day 1)
Overall Study STARTED	3	3	3	3
Overall Study COMPLETED	3	3	3	3
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Dose-Finding Study of DTX401 (AAV8G6PC) in Adults With Glycogen Storage Disease Type Ia (GSDIa)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTX401 Cohort 1 n=3 Participants DTX401 Dose 1 (2.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 2 n=3 Participants DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 3 n=3 Participants DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with an optimized reactive steroid regimen (7 weeks, at a starting dose of 60 mg/day, after ALT elevation)	DTX401 Cohort 4 n=3 Participants DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a prophylactic steroid regimen (8 weeks, at a starting dose of 60 mg/day, starting on Day 1)	Total n=12 Participants Total of all reporting groups
Age, Continuous	45.3 years STANDARD_DEVIATION 15.3 • n=99 Participants	29.7 years STANDARD_DEVIATION 10.1 • n=107 Participants	26.0 years STANDARD_DEVIATION 13.9 • n=206 Participants	25.0 years STANDARD_DEVIATION 5.2 • n=157 Participants	31.5 years STANDARD_DEVIATION 13.2 • n=390 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	1 Participants n=157 Participants	4 Participants n=390 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	3 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=157 Participants	8 Participants n=390 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	1 Participants n=390 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=157 Participants	11 Participants n=390 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=157 Participants	12 Participants n=390 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Controlled Fasting Challenge: Time to First Hypoglycemic Event	4.4 hours STANDARD_DEVIATION 0.9 • n=99 Participants	4.5 hours STANDARD_DEVIATION 1.4 • n=107 Participants	2.3 hours STANDARD_DEVIATION 1.2 • n=206 Participants	2.5 hours STANDARD_DEVIATION 0.9 • n=157 Participants	3.4 hours STANDARD_DEVIATION 1.4 • n=390 Participants

PRIMARY outcome

Timeframe: AEs Prior to Dosing: From signing the informed consent form (ICF) to first dose of study drug. TEAEs: From first dose of study drug through the End of Study (EOS)/Early Withdrawal visit (up to Week 52) plus 30 days.

Outcome measures

Outcome measures
Measure	DTX401 Cohort 1 n=3 Participants DTX401 Dose 1 (2.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 2 n=3 Participants DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 3 n=3 Participants DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with an optimized reactive steroid regimen (7 weeks, at a starting dose of 60 mg/day, after ALT elevation)	DTX401 Cohort 4 n=3 Participants DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a prophylactic steroid regimen (8 weeks, at a starting dose of 60 mg/day, starting on Day 1)
Number of Participants With Adverse Events (AEs) Treatment-Emergent AEs (TEAEs) Serious TEAEs, Discontinuations Due to TEAEs, and Dose-Limiting Toxicities (DLTs) Any TEAE	3 Participants	3 Participants	3 Participants	3 Participants
Number of Participants With Adverse Events (AEs) Treatment-Emergent AEs (TEAEs) Serious TEAEs, Discontinuations Due to TEAEs, and Dose-Limiting Toxicities (DLTs) Any AE prior to dosing	1 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Adverse Events (AEs) Treatment-Emergent AEs (TEAEs) Serious TEAEs, Discontinuations Due to TEAEs, and Dose-Limiting Toxicities (DLTs) Related TEAE	3 Participants	3 Participants	3 Participants	3 Participants
Number of Participants With Adverse Events (AEs) Treatment-Emergent AEs (TEAEs) Serious TEAEs, Discontinuations Due to TEAEs, and Dose-Limiting Toxicities (DLTs) Serious TEAE	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events (AEs) Treatment-Emergent AEs (TEAEs) Serious TEAEs, Discontinuations Due to TEAEs, and Dose-Limiting Toxicities (DLTs) Serious related TEAE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs) Treatment-Emergent AEs (TEAEs) Serious TEAEs, Discontinuations Due to TEAEs, and Dose-Limiting Toxicities (DLTs) Grade 3 or 4 TEAE	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events (AEs) Treatment-Emergent AEs (TEAEs) Serious TEAEs, Discontinuations Due to TEAEs, and Dose-Limiting Toxicities (DLTs) Dose-limiting toxicity	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs) Treatment-Emergent AEs (TEAEs) Serious TEAEs, Discontinuations Due to TEAEs, and Dose-Limiting Toxicities (DLTs) TEAE leading to study discontinuation	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs) Treatment-Emergent AEs (TEAEs) Serious TEAEs, Discontinuations Due to TEAEs, and Dose-Limiting Toxicities (DLTs) TEAE leading to death	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52

Population: Participants with an assessment at given time point

The change from baseline in time (in hours) to first hypoglycemic event (defined as glucose \< 54 mg/dL \[\< 3.0 mmol/L\]) during a controlled fasting challenge at 12, 24, and 52 weeks after IV administration of DTX401. A positive change from baseline is favorable.

Outcome measures

Outcome measures
Measure	DTX401 Cohort 1 n=3 Participants DTX401 Dose 1 (2.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 2 n=3 Participants DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 3 n=3 Participants DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with an optimized reactive steroid regimen (7 weeks, at a starting dose of 60 mg/day, after ALT elevation)	DTX401 Cohort 4 n=3 Participants DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a prophylactic steroid regimen (8 weeks, at a starting dose of 60 mg/day, starting on Day 1)
Change From Baseline in Time to First Hypoglycemic Event Over Time Change at Week 12	3.3 hours Standard Deviation 2.0	1.7 hours Standard Deviation 0.6	1.4 hours Standard Deviation 0.8	—
Change From Baseline in Time to First Hypoglycemic Event Over Time Change at Week 24	4.3 hours Standard Deviation 4.2	0.5 hours Standard Deviation 0.6	0.7 hours Standard Deviation 1.7	0.3 hours Standard Deviation NA 1 participant analyzed
Change From Baseline in Time to First Hypoglycemic Event Over Time Change at Week 52	4.2 hours Standard Deviation 2.2	-1.8 hours Standard Deviation 1.7	-0.6 hours Standard Deviation 0.1	3.6 hours Standard Deviation 2.7

Adverse Events

DTX401 Cohort 1

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

DTX401 Cohort 2

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

DTX401 Cohort 3

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

DTX401 Cohort 4

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Total

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DTX401 Cohort 1 n=3 participants at risk DTX401 Dose 1 (2.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 2 n=3 participants at risk DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 3 n=3 participants at risk DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with an optimized reactive steroid regimen (7 weeks, at a starting dose of 60 mg/day, after ALT elevation)	DTX401 Cohort 4 n=3 participants at risk DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a prophylactic steroid regimen (8 weeks, at a starting dose of 60 mg/day, starting on Day 1)	Total n=12 participants at risk DTX401 Dose 1 (2.0 × 10\^12 GC/kg) or DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation), an optimized reactive steroid regimen (7 weeks, at a starting dose of 60 mg/day, after ALT elevation), or a prophylactic steroid regimen (8 weeks, at a starting dose of 60 mg/day, starting on Day 1)
Infections and infestations Cellulitis	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Metabolism and nutrition disorders Lactic Acidosis	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Metabolism and nutrition disorders Metabolic Disorder	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Nervous system disorders Migraine	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.

Other adverse events

Other adverse events
Measure	DTX401 Cohort 1 n=3 participants at risk DTX401 Dose 1 (2.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 2 n=3 participants at risk DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation)	DTX401 Cohort 3 n=3 participants at risk DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with an optimized reactive steroid regimen (7 weeks, at a starting dose of 60 mg/day, after ALT elevation)	DTX401 Cohort 4 n=3 participants at risk DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a prophylactic steroid regimen (8 weeks, at a starting dose of 60 mg/day, starting on Day 1)	Total n=12 participants at risk DTX401 Dose 1 (2.0 × 10\^12 GC/kg) or DTX401 Dose 2 (6.0 × 10\^12 GC/kg) with a reactive steroid regimen (6 weeks, at a starting dose of 40 mg/day, after ALT elevation), an optimized reactive steroid regimen (7 weeks, at a starting dose of 60 mg/day, after ALT elevation), or a prophylactic steroid regimen (8 weeks, at a starting dose of 60 mg/day, starting on Day 1)
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Cardiac disorders Tachycardia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Endocrine disorders Adrenal Insufficiency	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Endocrine disorders Adrenal Suppression	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Endocrine disorders Glucocorticoid Deficiency	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Gastrointestinal disorders Abdominal Distension	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Gastrointestinal disorders Constipation	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	41.7% 5/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Gastrointestinal disorders Gastrointestinal Disorder	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Gastrointestinal disorders Malabsorption	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Gastrointestinal disorders Mouth Ulceration	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Gastrointestinal disorders Nausea	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 4/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Gastrointestinal disorders Toothache	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Gastrointestinal disorders Vomiting	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	41.7% 5/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
General disorders Asthenia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
General disorders Chills	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
General disorders Face Oedema	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
General disorders Fatigue	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
General disorders Hunger	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
General disorders Pyrexia	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
General disorders Thirst	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Hepatobiliary disorders Hepatic Pain	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Immune system disorders Food Allergy	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Immune system disorders Hypersensitivity	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Abdominal Wall Infection	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Covid-19	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Folliculitis	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Gastroenteritis	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Gastrointestinal Infection	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Gastrointestinal Viral Infection	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Hordeolum	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Infection	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Influenza	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Nasopharyngitis	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Oral Candidiasis	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Sinobronchitis	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Sinusitis	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Tinea Pedis	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Upper Respiratory Tract Infection	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	25.0% 3/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Urinary Tract Infection	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Infections and infestations Viral Infection	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Injury, poisoning and procedural complications Arthropod Bite	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Injury, poisoning and procedural complications Stoma Site Discomfort	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Investigations Alanine Aminotransferase Increased	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	50.0% 6/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Investigations Aspartate Aminotransferase Increased	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Investigations Blood Creatine Phosphokinase Increased	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 4/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Investigations Blood Creatinine Increased	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Investigations Blood Glucose Fluctuation	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Investigations Blood Uric Acid Increased	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Investigations Heart Rate Increased	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Investigations Hepatic Enzyme Increased	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Investigations Liver Function Test Increased	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	25.0% 3/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Investigations Weight Decreased	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 4/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Metabolism and nutrition disorders Hypertriglyceridaemia	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	25.0% 3/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Metabolism and nutrition disorders Hypoglycaemia	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 4/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Metabolism and nutrition disorders Lactic Acidosis	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Metabolism and nutrition disorders Vitamin D Deficiency	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Musculoskeletal and connective tissue disorders Arthralgia	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	25.0% 3/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Musculoskeletal and connective tissue disorders Gouty Arthritis	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Musculoskeletal and connective tissue disorders Joint Noise	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Musculoskeletal and connective tissue disorders Muscle Spasms	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	25.0% 3/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Musculoskeletal and connective tissue disorders Plantar Fasciitis	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Nervous system disorders Dizziness	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Nervous system disorders Headache	100.0% 3/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 8/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Nervous system disorders Migraine	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Nervous system disorders Tremor	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Psychiatric disorders Agitation	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Psychiatric disorders Anxiety	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	25.0% 3/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Psychiatric disorders Insomnia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Psychiatric disorders Libido Increased	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Renal and urinary disorders Nephrolithiasis	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	25.0% 3/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Renal and urinary disorders Proteinuria	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Reproductive system and breast disorders Prostatitis	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Congestion	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Skin and subcutaneous tissue disorders Hair Growth Abnormal	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	16.7% 2/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	66.7% 2/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	25.0% 3/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Skin and subcutaneous tissue disorders Skin Striae	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Skin and subcutaneous tissue disorders Skin Ulcer	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.
Vascular disorders Hypertension	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	33.3% 1/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	0.00% 0/3 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.	8.3% 1/12 • From enrollment (all-cause mortality) or first dose of study drug (treatment emergent adverse events) through the End of Study/Early Withdrawal visit (up to Week 52) plus 30 days. Per protocol, SAEs that occurred \> 30 days after EOS or Early withdrawal visit, did not need to be reported unless Investigator considered them related to study product.

Additional Information

Medical Information

Ultragenyx Pharmaceutical Inc

Phone: 1-888-756-8657

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER