Trial Outcomes & Findings for A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis (NCT NCT03486912)

NCT ID: NCT03486912

Last Updated: 2022-10-13

Results Overview

An improvement in fibrosis is defined as a decrease of fibrosis by ≥1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score at week 48 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) by ≥1 point. Worsening of fibrosis is defined as an increase of fibrosis by ≥1 point as determined by the NASH CRN Fibrosis Score.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 155 participants
• Primary outcome timeframe: From first dose to 48 weeks after first dose
• Results posted on: 2022-10-13

Participant Flow

Participant milestones

Measure	BMS-986036 10 mg BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg BMS-986036 40 mg administered subcutaneously once weekly	Placebo Placebo matching BMS-986036 administered subcutaneously once weekly
Randomized (Pre-Treatment) STARTED	39	38	39	39
Randomized (Pre-Treatment) COMPLETED	39	37	39	39
Randomized (Pre-Treatment) NOT COMPLETED	0	1	0	0
Treatment Period STARTED	39	37	39	39
Treatment Period COMPLETED	35	31	34	34
Treatment Period NOT COMPLETED	4	6	5	5

Reasons for withdrawal

Measure	BMS-986036 10 mg BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg BMS-986036 40 mg administered subcutaneously once weekly	Placebo Placebo matching BMS-986036 administered subcutaneously once weekly
Randomized (Pre-Treatment) Withdrawal by Subject	0	1	0	0
Treatment Period Withdrawal by Subject	3	3	3	2
Treatment Period Other Reasons	0	2	1	1
Treatment Period Adverse Event	0	1	1	0
Treatment Period Lost to Follow-up	1	0	0	2

Baseline Characteristics

A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis

Baseline characteristics by cohort

Measure	BMS-986036 10 mg n=39 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=38 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=39 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=39 Participants Placebo matching BMS-986036 administered subcutaneously once weekly	Total n=155 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	30 Participants n=7 Participants	30 Participants n=5 Participants	25 Participants n=4 Participants	112 Participants n=21 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	14 Participants n=4 Participants	43 Participants n=21 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	26 Participants n=7 Participants	21 Participants n=5 Participants	24 Participants n=4 Participants	99 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants	15 Participants n=4 Participants	56 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	11 Participants n=4 Participants	37 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	30 Participants n=7 Participants	31 Participants n=5 Participants	28 Participants n=4 Participants	114 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	31 Participants n=7 Participants	34 Participants n=5 Participants	33 Participants n=4 Participants	128 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants

PRIMARY outcome

Timeframe: From first dose to 48 weeks after first dose

Population: All treated participants

An improvement in fibrosis is defined as a decrease of fibrosis by ≥1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score at week 48 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage.

Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) by ≥1 point. Worsening of fibrosis is defined as an increase of fibrosis by ≥1 point as determined by the NASH CRN Fibrosis Score.

Outcome measures

Measure	BMS-986036 10 mg n=39 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=37 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=39 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=39 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48	28.2 Percentage of Participants	24.3 Percentage of Participants	28.2 Percentage of Participants	30.8 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 48 weeks after first dose

Population: All treated participants

An improvement in Ishak fibrosis is defined as a decrease of fibrosis by ≥ 1-stage in the Ishak fibrosis score at week 48 in liver biopsy. ISHAKs uses a 0-6 scale: 1: centrilobular pericellular fibrosis, 2: centrilobular and periportal fibrosis, 3: bridging fibrosis (few bridges), 4: bridging fibrosis (many bridges), 5: early or incomplete cirrhosis, 6: established or advanced cirrhosis.

Outcome measures

Measure	BMS-986036 10 mg n=39 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=37 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=39 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=39 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48	38.5 Percentage of Participants	32.4 Percentage of Participants	33.3 Percentage of Participants	35.9 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 48 weeks after first dose

Population: All treated participants

The percentage of participants who achieved a ≥1-stage improvement in fibrosis without worsening of NASH or NASH improvement with no worsening of fibrosis at week 48 in liver biopsy. Improvement in fibrosis is defined by the NASH Clinical Research Network (CRN) Fibrosis Score. Improvement in NASH is defined by a ≥2-stage decrease in the nonalcoholic fatty liver disease activity score (NAS). NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Measure	BMS-986036 10 mg n=39 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=37 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=39 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=39 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48	33.3 Percentage of Participants	40.5 Percentage of Participants	35.9 Percentage of Participants	30.8 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 48 weeks after first dose

Population: All treated participants

An improvement in fibrosis is defined as a decrease of ≥ 1-stage in the non-alcoholic steatohepatitis clinical research network (NASH CRN) Fibrosis Score at week 48 in liver biopsy. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Measure	BMS-986036 10 mg n=39 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=37 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=39 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=39 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 48	35.9 Percentage of Participants	29.7 Percentage of Participants	28.2 Percentage of Participants	33.3 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 48 weeks after first dose

Population: All treated participants

An improvement in CPA is defined as any decrease in CPA at week 48 in liver biopsy.

Outcome measures

Measure	BMS-986036 10 mg n=39 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=37 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=39 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=39 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 48	61.8 Percentage of Participants	54.2 Percentage of Participants	41.9 Percentage of Participants	53.1 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 48 weeks after first dose

Population: All treated participants

NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1 at week 48 in liver biopsy. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade <2).

Outcome measures

Measure	BMS-986036 10 mg n=39 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=37 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=39 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=39 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 48	2.6 Percentage of Participants	5.4 Percentage of Participants	2.6 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 48 weeks after first dose

Population: All treated participants

The percentage of participants with NASH improvement at week 48 in liver biopsy. NASH improvement is defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by ≥ 2 points with contribution from > 1 NAS component. The NASH CRN system assesses liver biopsies for degree of steatosis (0-3), lobular inflammation (0-3), hepatocellular ballooning (0-2), and fibrosis (0-4). The 3 categories are added together in an unweighted fashion to determine the NAS, which ranges from 0 to 8.

Outcome measures

Measure	BMS-986036 10 mg n=39 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=37 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=39 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=39 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 48	15.4 Percentage of Participants	24.3 Percentage of Participants	12.8 Percentage of Participants	2.6 Percentage of Participants

Adverse Events

BMS-986036 10 mg

Serious events: 7 serious events

Other events: 27 other events

Deaths: 1 deaths

BMS-986036 20 mg

Serious events: 7 serious events

Other events: 36 other events

Deaths: 0 deaths

BMS-986036 40 mg

Serious events: 8 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 33 other events

Deaths: 1 deaths

Serious adverse events

Measure	BMS-986036 10 mg n=39 participants at risk BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=37 participants at risk BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=39 participants at risk BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=39 participants at risk Placebo matching BMS-986036 administered subcutaneously once weekly
Blood and lymphatic system disorders Anaemia	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Cardiac disorders Acute coronary syndrome	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Cardiac disorders Coronary artery disease	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Cardiac disorders Supraventricular tachycardia	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Ascites	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Pancreatitis	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Hepatobiliary disorders Cholelithiasis	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Appendicitis	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations COVID-19	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations COVID-19 pneumonia	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Clostridium difficile infection	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Diverticulitis	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Norovirus infection	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Injury, poisoning and procedural complications Meniscus injury	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Metabolism and nutrition disorders Dehydration	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Nervous system disorders Cerebral haemorrhage	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Nervous system disorders Spondylitic myelopathy	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Nervous system disorders Syncope	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Renal and urinary disorders Acute kidney injury	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Renal and urinary disorders Glomerulonephritis membranoproliferative	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Renal and urinary disorders Ureterolithiasis	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.

Other adverse events

Measure	BMS-986036 10 mg n=39 participants at risk BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=37 participants at risk BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=39 participants at risk BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=39 participants at risk Placebo matching BMS-986036 administered subcutaneously once weekly
General disorders Injection site pain	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Cardiac disorders Palpitations	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Abdominal distension	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.3% 4/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Abdominal pain	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	16.2% 6/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Abdominal pain upper	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	8.1% 3/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Abdominal tenderness	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Constipation	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.3% 4/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Diarrhoea	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	43.2% 16/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	28.2% 11/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	15.4% 6/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Flatulence	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Frequent bowel movements	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	16.2% 6/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	12.8% 5/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Nausea	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	29.7% 11/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	17.9% 7/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	12.8% 5/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Varices oesophageal	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Gastrointestinal disorders Vomiting	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
General disorders Fatigue	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	16.2% 6/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
General disorders Injection site bruising	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	18.9% 7/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.3% 4/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
General disorders Injection site erythema	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	12.8% 5/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
General disorders Injection site reaction	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
General disorders Injection site swelling	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
General disorders Oedema peripheral	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
General disorders Peripheral swelling	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Acute sinusitis	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Bronchitis	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.8% 4/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Cellulitis	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Ear infection	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Furuncle	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Gastroenteritis	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Gastroenteritis viral	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Influenza	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Nasopharyngitis	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.8% 4/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	12.8% 5/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Pharyngitis streptococcal	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Respiratory tract infection	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Sinusitis	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	13.5% 5/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.3% 4/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Upper respiratory tract infection	12.8% 5/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.8% 4/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	12.8% 5/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Infections and infestations Urinary tract infection	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.3% 4/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	12.8% 5/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Injury, poisoning and procedural complications Contusion	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Injury, poisoning and procedural complications Fall	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Investigations Glycosylated haemoglobin increased	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Investigations Vitamin D decreased	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Investigations Weight increased	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Investigations White blood cells urine positive	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	8.1% 3/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Metabolism and nutrition disorders Diabetes mellitus	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Metabolism and nutrition disorders Hypoglycaemia	10.3% 4/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Metabolism and nutrition disorders Increased appetite	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	16.2% 6/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Metabolism and nutrition disorders Type 2 diabetes mellitus	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	8.1% 3/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Metabolism and nutrition disorders Vitamin D deficiency	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	15.4% 6/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	12.8% 5/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Musculoskeletal and connective tissue disorders Muscle spasms	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.8% 4/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	8.1% 3/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Nervous system disorders Dizziness	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Nervous system disorders Headache	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.8% 4/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	12.8% 5/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Renal and urinary disorders Nephrolithiasis	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Renal and urinary disorders Proteinuria	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.3% 4/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	7.7% 3/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Respiratory, thoracic and mediastinal disorders Sinus congestion	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Skin and subcutaneous tissue disorders Dermatitis contact	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.7% 1/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Skin and subcutaneous tissue disorders Erythema	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Skin and subcutaneous tissue disorders Pruritus	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Skin and subcutaneous tissue disorders Rash	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	8.1% 3/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.1% 2/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	10.8% 4/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
Vascular disorders Hypertension	0.00% 0/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	5.4% 2/37 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.	2.6% 1/39 • Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks). All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email:

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER