Trial Outcomes & Findings for A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis (NCT NCT04308681)

Last Updated: 2026-02-03

Results Overview

Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for the IPF cohort only as pre-specified in the protocol.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

403 participants

Primary outcome timeframe

From baseline (first dose) up to week 26

Results posted on

2026-02-03

Participant Flow

Participants who received 30 mg or 60 mg BMS-986278 in the 26-week long main study phase and met low BP criteria were given the option to receive 10 mg of BMS-986278 in the optional treatment extension (OTE), which lasted an additional 26 weeks. Participants who received placebo during the main study phase were re-randomized to receive either 30 mg or 60 mg of BMS-986278 in OTE. No participants received a 10 mg dose during the main study and no participants received placebo during the OTE.

Participant milestones

Participant milestones
Measure	IPF Cohort: Placebo Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	IPF Cohort - BMS-986278 10mg Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 10 mg of BMS-986278 twice per day during the Optional Treatment Extension (OTE) phase only.	PF-ILD Cohort: Placebo Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort - 10mg BMS-986278 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 10 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase only. This arm includes participants who received 30 mg or 60 mg BMS-986278 BID in the main study who meet low BP criteria and were dose reduced to 10 mg BMS-986278 BID for the OTE.
Pre-Treatment STARTED	93	92	93	0	41	42	42	0
Pre-Treatment COMPLETED	92	91	93	0	41	40	42	0
Pre-Treatment NOT COMPLETED	1	1	0	0	0	2	0	0
Treatment up to Week 26 STARTED	92	91	93	0	41	40	42	0
Treatment up to Week 26 COMPLETED	82	82	84	0	33	37	40	0
Treatment up to Week 26 NOT COMPLETED	10	9	9	0	8	3	2	0
OTE - 26 Weeks STARTED	0	100	102	11	0	41	46	4
OTE - 26 Weeks PBO BMS-986278 30 mg	0	33	0	0	0	13	0	0
OTE - 26 Weeks PBO BMS-986278 60 mg	0	0	30	0	0	0	14	0
OTE - 26 Weeks COMPLETED	0	96	89	8	0	39	42	4
OTE - 26 Weeks NOT COMPLETED	0	4	13	3	0	2	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	IPF Cohort: Placebo Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	IPF Cohort - BMS-986278 10mg Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 10 mg of BMS-986278 twice per day during the Optional Treatment Extension (OTE) phase only.	PF-ILD Cohort: Placebo Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Pre-Treatment Not reported	1	1	0	0	0	2	0
Treatment up to Week 26 Withdrawal by participant	2	1	1	0	0	1	1
Treatment up to Week 26 Other reasons	2	0	0	0	1	1	0
Treatment up to Week 26 Participant no longer meets study criteria	0	1	2	0	1	0	1
Treatment up to Week 26 Adverse Event	6	5	5	0	6	1	0
Treatment up to Week 26 Adverse event unrelated to study drug	0	2	1	0	0	0	0
OTE - 26 Weeks Withdrawal by participant	0	0	4	0	0	0	1
OTE - 26 Weeks Death	0	1	0	0	0	0	1
OTE - 26 Weeks Adverse Event	0	2	8	3	0	1	2
OTE - 26 Weeks Adverse event unrelated to study drug	0	1	1	0	0	1	0

Baseline Characteristics

A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IPF Cohort: Placebo n=92 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=91 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=93 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=41 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=40 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=42 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.	Total n=399 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=15 Participants	1 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants	0 Participants n=153 Participants	1 Participants n=615 Participants
Race (NIH/OMB) Asian	25 Participants n=13 Participants	25 Participants n=15 Participants	27 Participants n=28 Participants	8 Participants n=2 Participants	9 Participants n=32 Participants	6 Participants n=153 Participants	100 Participants n=615 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants	0 Participants n=153 Participants	0 Participants n=615 Participants
Race (NIH/OMB) Black or African American	1 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	2 Participants n=32 Participants	0 Participants n=153 Participants	3 Participants n=615 Participants
Race (NIH/OMB) White	65 Participants n=13 Participants	64 Participants n=15 Participants	64 Participants n=28 Participants	31 Participants n=2 Participants	27 Participants n=32 Participants	32 Participants n=153 Participants	283 Participants n=615 Participants
Age, Continuous	69.0 Years STANDARD_DEVIATION 6.70 • n=13 Participants	69.5 Years STANDARD_DEVIATION 7.31 • n=15 Participants	68.8 Years STANDARD_DEVIATION 7.85 • n=28 Participants	68.8 Years STANDARD_DEVIATION 8.06 • n=2 Participants	71.4 Years STANDARD_DEVIATION 7.92 • n=32 Participants	67.9 Years STANDARD_DEVIATION 8.41 • n=153 Participants	69.5 Years STANDARD_DEVIATION 8.22 • n=615 Participants
Sex: Female, Male Female	16 Participants n=13 Participants	14 Participants n=15 Participants	24 Participants n=28 Participants	21 Participants n=2 Participants	17 Participants n=32 Participants	20 Participants n=153 Participants	112 Participants n=615 Participants
Sex: Female, Male Male	76 Participants n=13 Participants	77 Participants n=15 Participants	69 Participants n=28 Participants	20 Participants n=2 Participants	23 Participants n=32 Participants	22 Participants n=153 Participants	287 Participants n=615 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=13 Participants	18 Participants n=15 Participants	19 Participants n=28 Participants	7 Participants n=2 Participants	6 Participants n=32 Participants	9 Participants n=153 Participants	80 Participants n=615 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=13 Participants	36 Participants n=15 Participants	37 Participants n=28 Participants	19 Participants n=2 Participants	21 Participants n=32 Participants	22 Participants n=153 Participants	174 Participants n=615 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	32 Participants n=13 Participants	37 Participants n=15 Participants	37 Participants n=28 Participants	15 Participants n=2 Participants	13 Participants n=32 Participants	11 Participants n=153 Participants	145 Participants n=615 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants	0 Participants n=153 Participants	0 Participants n=615 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=13 Participants	2 Participants n=15 Participants	1 Participants n=28 Participants	2 Participants n=2 Participants	2 Participants n=32 Participants	4 Participants n=153 Participants	12 Participants n=615 Participants

PRIMARY outcome

Timeframe: From baseline (first dose) up to week 26

Population: All treated participants in the IPF Cohort with baseline and week 26 results. Prespecified to be collected for IPF Cohort only.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=70 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=59 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=67 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants	-2.807 Percent change from baseline in ppFVC Standard Error 0.7286	-3.068 Percent change from baseline in ppFVC Standard Error 0.7335	-1.120 Percent change from baseline in ppFVC Standard Error 0.6691	—	—	—

SECONDARY outcome

Timeframe: From first dose up to 30 days after last dose during the main study treatment phase

Population: All treated participants

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=92 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=91 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=93 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=41 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=40 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=42 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
The Number of Participants Experiencing Adverse Events (AEs)	74 Participants	69 Participants	69 Participants	32 Participants	33 Participants	28 Participants

SECONDARY outcome

Timeframe: From first dose up to 30 days after last dose during the main study treatment phase

Population: All treated participants

A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=92 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=91 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=93 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=41 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=40 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=42 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
The Number of Participants Experiencing Serious Adverse Events (SAEs)	16 Participants	10 Participants	10 Participants	13 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: From first dose up to 30 days after last dose during the main study treatment phase

Population: All treated participants

The number of participants who discontinued study treatment due to adverse events (AEs)

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=92 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=91 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=93 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=41 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=40 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=42 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	9 Participants	9 Participants	6 Participants	7 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose up to 30 days after last dose during the main study treatment phase

Population: All treated participants

The number of participants who died while receiving study treatment due to an adverse event

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=92 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=91 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=93 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=41 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=40 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=42 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
The Number of Participants Who Died Due to Adverse Events (AEs)	2 Participants	3 Participants	4 Participants	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: On Day 1 and Week 4 (Day 29)

Population: All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data

Cmax is defined as the maximum concentration of the analyte recorded in the participants. Cmax of BMS-986278 and BMT-327319 was derived from plasma concentration versus time data.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=8 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=13 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=2 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=2 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Maximum Concentration (Cmax) Day 1; Analyte: BMT-323719	—	114.66 ng/mL Geometric Coefficient of Variation 32.147	167.35 ng/mL Geometric Coefficient of Variation 39.538	—	94.8 ng/mL Geometric Coefficient of Variation 10.39	189.6 ng/mL Geometric Coefficient of Variation 86.07
Maximum Concentration (Cmax) Day 29; Analyte: BMS-986278	—	641.0 ng/mL Geometric Coefficient of Variation 27.68	1301.3 ng/mL Geometric Coefficient of Variation 20.80	—	691.9 ng/mL Geometric Coefficient of Variation 2.04	1247.80 ng/mL Geometric Coefficient of Variation 29.84
Maximum Concentration (Cmax) Day 29; Analyte: BMT-323719	—	169.30 ng/mL Geometric Coefficient of Variation 28.104	275.82 ng/mL Geometric Coefficient of Variation 34.554	—	161.9 ng/mL Geometric Coefficient of Variation 30.60	433.5 ng/mL Geometric Coefficient of Variation 58.73
Maximum Concentration (Cmax) Day 1; Analyte: BMS-986278	—	465.0 ng/mL Geometric Coefficient of Variation 36.23	1089.8 ng/mL Geometric Coefficient of Variation 42.06	—	715.4 ng/mL Geometric Coefficient of Variation 2.87	1112.3 ng/mL Geometric Coefficient of Variation 77.45

SECONDARY outcome

Timeframe: On Day 1 and Week 4 (Day 29)

Population: All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data

Tmax is defined as the amount of time until the maximum concentration of the analyte is recorded in the participants

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=8 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=13 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=2 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=2 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Time to Maximum Concentration (Tmax) Day 1; Analyte: BMS-986278	—	2.0170 Hours Interval 1.567 to 4.1	1.6670 Hours Interval 1.283 to 5.917	—	1.55 Hours Interval 1.5 to 1.6	2.01 Hours Interval 1.83 to 2.18
Time to Maximum Concentration (Tmax) Day 1; Analyte: BMT-323719	—	4.0670 Hours Interval 1.867 to 7.9	4.0330 Hours Interval 1.9 to 8.0	—	7.96 Hours Interval 7.92 to 8.0	4.10 Hours Interval 3.98 to 4.22
Time to Maximum Concentration (Tmax) Day 29; Analyte: BMS-986278	—	1.9080 Hours Interval 1.45 to 4.117	1.6750 Hours Interval 1.317 to 4.0	—	2.68 Hours Interval 1.533 to 3.82	4.06 Hours Interval 3.98 to 4.13
Time to Maximum Concentration (Tmax) Day 29; Analyte: BMT-323719	—	4.0670 Hours Interval 2.083 to 6.0	2.0085 Hours Interval 1.417 to 7.85	—	5.79 Hours Interval 4.1 to 7.48	3.74 Hours Interval 1.48 to 6.0

SECONDARY outcome

Timeframe: On Day 1 and Week 4 (Day 29)

Population: All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data

Area under the plasma concentration-time curve (AUC) from the timepoint of 0 hours to 24 hours post dose as measured on Day 1 and Week 4.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=7 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=12 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=2 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=2 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Area Under Curve (AUC0-8) Day 1; Analyte: BMS-986278	—	1990.4530 h*ng/mL Geometric Coefficient of Variation 20.78185	4430.5891 h*ng/mL Geometric Coefficient of Variation 31.16188	—	3358 h*ng/mL Geometric Coefficient of Variation 8.7	4347 h*ng/mL Geometric Coefficient of Variation 61.3
Area Under Curve (AUC0-8) Day 1; Analyte: BMT-323719	—	686.2045 h*ng/mL Geometric Coefficient of Variation 32.95587	913.4300 h*ng/mL Geometric Coefficient of Variation 50.72949	—	532 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation not calculated due to insufficient number of events	2081 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation not calculated due to insufficient number of events
Area Under Curve (AUC0-8) Day 29; Analyte: BMS-986278	—	2853.9081 h*ng/mL Geometric Coefficient of Variation 21.72108	5433.1662 h*ng/mL Geometric Coefficient of Variation 25.62819	—	3591 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation not calculated due to insufficient number of events	8107 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation not calculated due to insufficient number of events
Area Under Curve (AUC0-8) Day 29; Analyte: BMT-323719	—	1179.6486 h*ng/mL Geometric Coefficient of Variation 31.27987	1784.7369 h*ng/mL Geometric Coefficient of Variation 30.32795	—	—	2839 h*ng/mL Geometric Coefficient of Variation 45.8

SECONDARY outcome

Timeframe: On Week 4 (Day 29) and Week 12 (Day 85)

Population: All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data

Ctrough is defined as the lowerst concentration of drug in the blood immediately before the next dose is administered

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=56 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=60 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=28 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=31 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Concentration Trough (Ctrough) Day 29-BMS-986278	—	92.1 ng/mL Interval 13.5 to 433.0	217 ng/mL Interval 32.4 to 1540.0	—	116.0000 ng/mL Interval 26.3 to 392.0	286.0000 ng/mL Interval 49.6 to 2659.0
Concentration Trough (Ctrough) Day 85-BMS-986278	—	84.2 ng/mL Interval 16.7 to 389.0	199 ng/mL Interval 5.37 to 726.0	—	88.7000 ng/mL Interval 20.1 to 380.0	196.0000 ng/mL Interval 68.0 to 1773.0
Concentration Trough (Ctrough) Day 29-BMT-323719	—	60.3 ng/mL Interval 12.9 to 207.0	141 ng/mL Interval 52.4 to 384.0	—	75.5000 ng/mL Interval 0.2 to 121.0	177.5000 ng/mL Interval 0.2 to 693.0
Concentration Trough (Ctrough) Day 85-BMT-323719	—	64.2 ng/mL Interval 0.2 to 174.0	132 ng/mL Interval 0.2 to 371.0	—	67.4500 ng/mL Interval 11.0 to 186.0	156.0000 ng/mL Interval 0.2 to 326.0

SECONDARY outcome

Timeframe: At Week 26

Population: All treated participants

A frequency summary of investigator clinical interpretation of ECG abnormal findings is listed.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=92 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=91 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=93 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=41 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=40 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=42 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
The Number of Participants Experiencing Electrocardiogram (ECG) Abnormalities	27 Participants	18 Participants	31 Participants	5 Participants	9 Participants	12 Participants

SECONDARY outcome

Timeframe: At baseline and Week 26

Population: All treated participants with baseline and week 26 vital sign measurement results.

The change from baseline in select vital sign measurements. Baseline is defined as first dose.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=77 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=72 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=79 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=27 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=33 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=37 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Change From Baseline in Vital Sign Measurements Sitting Diastolic Blood Pressure - 0 Hours Pre-Dose	0.0 Change from baseline in mmHg Interval -20.0 to 19.0	0.0 Change from baseline in mmHg Interval -21.0 to 20.0	1.0 Change from baseline in mmHg Interval -16.0 to 24.0	3.0 Change from baseline in mmHg Interval -9.0 to 13.0	1.0 Change from baseline in mmHg Interval -18.0 to 17.0	-1.0 Change from baseline in mmHg Interval -27.0 to 15.0
Change From Baseline in Vital Sign Measurements Standing Diastolic Blood Pressure - 0 Hours Pre-Dose	-2.0 Change from baseline in mmHg Interval -18.0 to 15.0	0.0 Change from baseline in mmHg Interval -28.0 to 22.0	1.0 Change from baseline in mmHg Interval -24.0 to 30.0	1.5 Change from baseline in mmHg Interval -15.0 to 26.0	-0.5 Change from baseline in mmHg Interval -14.0 to 20.0	0.0 Change from baseline in mmHg Interval -18.0 to 16.0
Change From Baseline in Vital Sign Measurements Supine Diastolic Blood Pressure - 0 Hours Pre-Dose	-1.0 Change from baseline in mmHg Interval -12.0 to 18.0	1.0 Change from baseline in mmHg Interval -25.0 to 17.0	1.0 Change from baseline in mmHg Interval -23.0 to 19.0	2.5 Change from baseline in mmHg Interval -13.0 to 15.0	0.0 Change from baseline in mmHg Interval -8.0 to 17.0	0.0 Change from baseline in mmHg Interval -14.0 to 14.0
Change From Baseline in Vital Sign Measurements Sitting Systolic Blood Pressure - 0 Hours Pre-Dose	-1.0 Change from baseline in mmHg Interval -29.0 to 37.0	1.0 Change from baseline in mmHg Interval -23.0 to 30.0	3.0 Change from baseline in mmHg Interval -22.0 to 34.0	0.0 Change from baseline in mmHg Interval -35.0 to 17.0	1.0 Change from baseline in mmHg Interval -22.0 to 37.0	-1.0 Change from baseline in mmHg Interval -49.0 to 34.0
Change From Baseline in Vital Sign Measurements Standing Systolic Blood Pressure - 0 Hours Pre-Dose	-3.0 Change from baseline in mmHg Interval -27.0 to 28.0	-1.5 Change from baseline in mmHg Interval -35.0 to 31.0	3.0 Change from baseline in mmHg Interval -28.0 to 36.0	0.5 Change from baseline in mmHg Interval -38.0 to 33.0	0.5 Change from baseline in mmHg Interval -23.0 to 28.0	0.0 Change from baseline in mmHg Interval -34.0 to 26.0
Change From Baseline in Vital Sign Measurements Supine Systolic Blood Pressure - 0 Hours Pre-Dose	0.0 Change from baseline in mmHg Interval -24.0 to 34.0	0.0 Change from baseline in mmHg Interval -25.0 to 43.0	3.0 Change from baseline in mmHg Interval -24.0 to 24.0	2.5 Change from baseline in mmHg Interval -29.0 to 25.0	2.0 Change from baseline in mmHg Interval -20.0 to 49.0	-3.0 Change from baseline in mmHg Interval -30.0 to 23.0

SECONDARY outcome

Timeframe: At baseline and Week 26

Population: All treated participants in the PF-ILD Cohort with baseline and week 26 results. Pre-specified to be collected for PF-ILD Cohort only.

Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for PF-ILD cohort only as pre-specified in the protocol.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=22 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=29 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=31 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in PF-ILD Participants	—	—	—	-2.681 Percent change from baseline Standard Error 1.4730	2.717 Percent change from baseline Standard Error 0.9054	-1.203 Percent change from baseline Standard Error 0.8808

SECONDARY outcome

Timeframe: At Weeks 4, 8, 12, 16, 20, and 26

Population: All treated participants with ppFVC data during visits at the specific time windows of Weeks 4, 8, 12, 16, 20, and 26.

The number of participants with ≥ 10% absolute decline in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant. The number of participants represented signify the number of participants with applicable data during the specific visit at the specific timepoint.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=78 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=75 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=75 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=35 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=30 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=36 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
The Number of Participants With ≥ 10% Absolute Decline in ppFVC (%) Week 4	3 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants With ≥ 10% Absolute Decline in ppFVC (%) Week 8	4 Participants	4 Participants	3 Participants	2 Participants	0 Participants	0 Participants
The Number of Participants With ≥ 10% Absolute Decline in ppFVC (%) Week 12	4 Participants	1 Participants	3 Participants	1 Participants	0 Participants	0 Participants
The Number of Participants With ≥ 10% Absolute Decline in ppFVC (%) Week 16	3 Participants	2 Participants	2 Participants	2 Participants	0 Participants	0 Participants
The Number of Participants With ≥ 10% Absolute Decline in ppFVC (%) Week 20	10 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants
The Number of Participants With ≥ 10% Absolute Decline in ppFVC (%) Week 26	7 Participants	7 Participants	4 Participants	3 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 26

Population: All treated participants with ppFVC data at the prespecified timepoints Weeks 4, 8, 12, 16, 20, and 26.

The number of participants with 0% change in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=78 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=75 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=75 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=35 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=30 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=36 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
The Number of Participants With 0% Change in ppFVC (%) Week 4	48 Participants	41 Participants	33 Participants	14 Participants	12 Participants	13 Participants
The Number of Participants With 0% Change in ppFVC (%) Week 8	47 Participants	43 Participants	69 Participants	15 Participants	13 Participants	12 Participants
The Number of Participants With 0% Change in ppFVC (%) Week 12	46 Participants	43 Participants	39 Participants	17 Participants	13 Participants	13 Participants
The Number of Participants With 0% Change in ppFVC (%) Week 16	51 Participants	45 Participants	39 Participants	15 Participants	11 Participants	18 Participants
The Number of Participants With 0% Change in ppFVC (%) Week 20	51 Participants	40 Participants	33 Participants	18 Participants	15 Participants	18 Participants
The Number of Participants With 0% Change in ppFVC (%) Week 26	53 Participants	42 Participants	34 Participants	17 Participants	22 Participants	19 Participants

SECONDARY outcome

Timeframe: From first dose up to the first occurrence of ≥ 10% absolute decline in ppFVC

Population: The total accumulated number of participants with ≥ 10% Absolute Decline in ppFVC events at any time from first dose up to Week 26. A participant's time was censored at the last observed time prior to discontinuation if a participant discontinues study without event, or at week 26 if a participant does not experience the event until the end of week 26.

The amount of time in weeks to the participant's first occurrence ≥ 10% absolute decline in Percent Predicted Forced Vital Capacity (ppFVC). A participant's time is censored at the last observed time prior to discontinuation if a participant discontinues study without event, or at week 26 if a participant does not experience the event until the end of week 26. Kaplan-Meier product limit method will be employed to estimate the survival curves. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=16 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=9 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=6 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=5 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=5 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=1 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Time to First Occurrence ≥ 10% Absolute Decline in ppFVC (%)	NA Weeks Median, lower limit, and upper limit not calculated due to insufficient number of events.	NA Weeks Median, lower limit, and upper limit not calculated due to insufficient number of events.	NA Weeks Median, lower limit, and upper limit not calculated due to insufficient number of events.	NA Weeks Median, lower and upper limit not calculated due to insufficient number of events.	NA Weeks Interval 26.3 to Median, lower limit, and upper limit not calculated due to insufficient number of events.	NA Weeks Median, lower limit, and upper limit not calculated due to insufficient number of events.

SECONDARY outcome

Timeframe: From baseline up to Weeks 4, 8, 12, 16, 20, and 26

Population: All treated participants with ppFVC data at Weeks 4, 8, 12, 16, 20, and 26

The absolute change in ppFVC (%) is measured from baseline up to the pre-specified timepoints of Weeks 4, 8, 12, 16, 20, and 26. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air (mL) exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=78 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=75 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=75 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=35 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=30 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=36 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) Absolute change from Baseline to Week 4	-1.491 Percentage of predicted value Standard Deviation 4.3773	-0.482 Percentage of predicted value Standard Deviation 4.2499	0.023 Percentage of predicted value Standard Deviation 5.4007	1.119 Percentage of predicted value Standard Deviation 6.0123	0.327 Percentage of predicted value Standard Deviation 3.1862	0.217 Percentage of predicted value Standard Deviation 3.5946
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) Absolute change from Baseline to Week 8	-1.783 Percentage of predicted value Standard Deviation 4.5234	-1.046 Percentage of predicted value Standard Deviation 4.8192	-1.079 Percentage of predicted value Standard Deviation 5.1294	-0.334 Percentage of predicted value Standard Deviation 7.6326	0.966 Percentage of predicted value Standard Deviation 3.2631	0.475 Percentage of predicted value Standard Deviation 3.2802
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) Absolute change from Baseline to Week 12	-1.974 Percentage of predicted value Standard Deviation 5.0324	-0.589 Percentage of predicted value Standard Deviation 4.8575	-1.109 Percentage of predicted value Standard Deviation 5.9152	-2.012 Percentage of predicted value Standard Deviation 5.5436	0.114 Percentage of predicted value Standard Deviation 4.2490	0.196 Percentage of predicted value Standard Deviation 3.7168
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) Absolute change from Baseline to Week 16	-2.422 Percentage of predicted value Standard Deviation 5.0040	-1.042 Percentage of predicted value Standard Deviation 5.1644	-1.220 Percentage of predicted value Standard Deviation 4.3475	-1.180 Percentage of predicted value Standard Deviation 7.6897	-0.197 Percentage of predicted value Standard Deviation 4.5490	-0.394 Percentage of predicted value Standard Deviation 4.3439
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) Absolute change from Baseline to Week 20	-2.625 Percentage of predicted value Standard Deviation 4.8978	-1.717 Percentage of predicted value Standard Deviation 3.9049	-0.387 Percentage of predicted value Standard Deviation 4.2802	-2.650 Percentage of predicted value Standard Deviation 4.2813	-0.382 Percentage of predicted value Standard Deviation 4.6328	-0.272 Percentage of predicted value Standard Deviation 6.0198
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) Absolute change from Baseline to Week 26	-2.807 Percentage of predicted value Standard Deviation 6.0959	-3.068 Percentage of predicted value Standard Deviation 5.6339	-1.120 Percentage of predicted value Standard Deviation 5.4768	-2.681 Percentage of predicted value Standard Deviation 6.9089	-2.717 Percentage of predicted value Standard Deviation 4.8758	-1.203 Percentage of predicted value Standard Deviation 4.9043

SECONDARY outcome

Timeframe: From baseline up to Weeks 4, 8, 12, 16, 20, and 26

Population: All treated participants with FVC data at Weeks 4, 8, 12, 16, 20, and 26

Forced vital capacity (FVC) is defined as the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. The absolute change in FVC (mL) is measured from baseline up to Weeks 4, 8, 12, 16, 20, and 26.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=78 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=75 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=75 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=35 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=30 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=36 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Absolute Change From Baseline in Forced Vital Capacity (FVC) Absolute change from Baseline to Week 4	-54.7 mL Standard Deviation 153.50	-21.2 mL Standard Deviation 142.25	4.3 mL Standard Deviation 181.75	39.1 mL Standard Deviation 152.57	6.0 mL Standard Deviation 107.11	-0.30 mL Standard Deviation 113.07
Absolute Change From Baseline in Forced Vital Capacity (FVC) Absolute change from Baseline to Week 8	-62.7 mL Standard Deviation 157.81	-38.2 mL Standard Deviation 173.96	-36.1 mL Standard Deviation 165.74	-8.8 mL Standard Deviation 180.10	24.7 mL Standard Deviation 92.87	11.2 mL Standard Deviation 106.11
Absolute Change From Baseline in Forced Vital Capacity (FVC) Absolute change from Baseline to Week 12	-75.5 mL Standard Deviation 184.02	-27.2 mL Standard Deviation 173.23	-35.4 mL Standard Deviation 176.48	-61.6 mL Standard Deviation 177.42	-1.5 mL Standard Deviation 129.64	0.9 mL Standard Deviation 128.40
Absolute Change From Baseline in Forced Vital Capacity (FVC) Absolute change from Baseline to Week 16	-88.2 mL Standard Deviation 183.44	-41.0 mL Standard Deviation 184.89	-45.8 mL Standard Deviation 152.79	-44.3 mL Standard Deviation 222.44	-22.8 mL Standard Deviation 146.75	-12.1 mL Standard Deviation 140.79
Absolute Change From Baseline in Forced Vital Capacity (FVC) Absolute change from Baseline to Week 20	-95.6 mL Standard Deviation 181.41	-70.0 mL Standard Deviation 142.70	-21.1 mL Standard Deviation 154.05	-84.6 mL Standard Deviation 134.01	-15.2 mL Standard Deviation 168.21	-3.9 mL Standard Deviation 222.29
Absolute Change From Baseline in Forced Vital Capacity (FVC) Absolute change from Baseline to Week 26	-106.4 mL Standard Deviation 214.94	-117.3 mL Standard Deviation 207.60	-48.8 mL Standard Deviation 184.97	-99.1 mL Standard Deviation 212.04	-100.0 mL Standard Deviation 166.30	-37.7 mL Standard Deviation 179.38

SECONDARY outcome

Timeframe: From baseline up to Week 26

Population: All treated participants with DLCO SB data at Week 26

The absolute change in single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=43 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=40 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=44 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=20 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=32 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=32 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Absolute Change From Baseline in Single Breath Diffusing Capacity of Carbon Monoxide (DLCO SB)	-0.4664 mL/min/mmHg Interval -17.023 to 5.725	-0.3418 mL/min/mmHg Interval -14.024 to 3.19	-0.4518 mL/min/mmHg Interval -5.449 to 3.888	-0.2352 mL/min/mmHg Interval -15.031 to 9.564	-0.3269 mL/min/mmHg Interval -8.902 to 2.086	-0.1829 mL/min/mmHg Interval -12.766 to 7.063

SECONDARY outcome

Timeframe: From baseline up to Week 26

Population: All treated participants with ppDLCO SB data at Week 26

The absolute change in percent predicted single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=44 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=40 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=44 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=21 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=33 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=34 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Absolute Change From Baseline in Percent Predicted Single Breath Diffusing Capacity of Carbon Monoxide (ppDLCO SB)	-1.4634 Percentage of predicted value Interval -38.133 to 64.451	-0.3470 Percentage of predicted value Interval -26.548 to 51.3	-3.2455 Percentage of predicted value Interval -48.939 to 35.463	-1.000 Percentage of predicted value Interval -22.176 to 11.587	-1.4683 Percentage of predicted value Interval -62.971 to 13.767	-1.4609 Percentage of predicted value Interval -13.016 to 20.997

SECONDARY outcome

Timeframe: From baseline up to Week 26

Population: All participants with evaluable 6MWT data at Week 26

The absolute change in walking endurance/distance as determined by the 6-minute walk test (6MWT) from baseline to Week 26. The 6-Minute Walk Test (6MWT) is a submaximal exercise test used to assess aerobic capacity and endurance. Baseline is defined as first dose.

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=67 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=62 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=70 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=25 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=33 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=37 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Absolute Change From Baseline in Walking Endurance/Distance	0.0 Meters Interval -495.0 to 119.0	3.0 Meters Interval -260.0 to 138.0	6.0 Meters Interval -370.0 to 92.0	11.0000 Meters Interval -315.833 to 175.0	0.0000 Meters Interval -220.0 to 188.4	-14.0000 Meters Interval -173.0 to 242.857

SECONDARY outcome

Timeframe: From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first

Population: All participants who experienced acute exacerbation

Time to first acute exacerbations of lung fibrosis was measured from the day of first dose up to the day of first acute exacerbation. Participants who discontinued the study treatment prior to the end of the main study without experiencing the event were excluded from the analysis. A participant's time was censored at the last observed time prior to discontinuation if a participant discontinued study without event, or at week 26 if a participant did not experience the event until the end of week 26. Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows: 1. Acute worsening or development of dyspnea (\< 1 month duration) 2. Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia 3. Respiratory deterioration not fully explained by cardiac failure or fluid overload

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=2 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=3 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=1 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=3 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=1 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Time to First Acute Exacerbation	NA Weeks Median, lower limit, and upper limit not calculated due to insufficient number of events.	NA Weeks Median, lower limit, and upper limit not calculated due to insufficient number of events.	NA Weeks Median, lower limit, and upper limit not calculated due to insufficient number of events.	NA Weeks Median, lower limit, and upper limit not calculated due to insufficient number of events.	—	NA Weeks Median, lower limit, and upper limit not calculated due to insufficient number of events.

SECONDARY outcome

Timeframe: From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first

Population: All treated participants

The number of participants experiencing acute exacerbations of lung fibrosis. Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows: 1. Acute worsening or development of dyspnea (\< 1 month duration) 2. Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia 3. Respiratory deterioration not fully explained by cardiac failure or fluid overload

Outcome measures

Outcome measures
Measure	IPF Cohort: Placebo n=92 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort: 30 mg BMS-986278 n=91 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort: 60 mg BMS-986278 n=93 Participants Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort: Placebo n=41 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort: 30 mg BMS-986278 n=40 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort: 60 mg BMS-986278 n=42 Participants Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
The Number of Participants Experiencing Acute Exacerbation	2 Participants	3 Participants	1 Participants	3 Participants	0 Participants	1 Participants

Adverse Events

IPF Cohort - Main Study - Placebo

Serious events: 16 serious events

Other events: 57 other events

Deaths: 4 deaths

IPF Cohort - Main Study - 30 mg BMS-986278

Serious events: 10 serious events

Other events: 54 other events

Deaths: 4 deaths

IPF Cohort - Main Study - BMS-986278 60mg

Serious events: 10 serious events

Other events: 51 other events

Deaths: 5 deaths

IPF Cohort - BMS-986278 10mg

Serious events: 4 serious events

Other events: 8 other events

Deaths: 3 deaths

IPF Cohort - OTE Phase - PBO BMS-986278 30 mg

Serious events: 19 serious events

Other events: 40 other events

Deaths: 4 deaths

IPF Cohort - OTE Phase - PBO BMS-986278 60mg

Serious events: 23 serious events

Other events: 43 other events

Deaths: 6 deaths

PF-ILD Cohort - Main Study - Placebo

Serious events: 13 serious events

Other events: 19 other events

Deaths: 4 deaths

PF-ILD Cohort - Main Study - BMS-986278 30mg

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

PF-ILD Cohort - Main Study - BMS-986278 60mg

Serious events: 6 serious events

Other events: 24 other events

Deaths: 0 deaths

PF-ILD Cohort - OTE Phase - BMS-986278 10mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PF-ILD Cohort - OTE Phase - PBO BMS-986278 30mg

Serious events: 8 serious events

Other events: 18 other events

Deaths: 1 deaths

PF-ILD Cohort - OTE Phase - PBO BMS-986278 60mg

Serious events: 7 serious events

Other events: 23 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	IPF Cohort - Main Study - Placebo n=92 participants at risk Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort - Main Study - 30 mg BMS-986278 n=91 participants at risk Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort - Main Study - BMS-986278 60mg n=93 participants at risk Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	IPF Cohort - BMS-986278 10mg n=11 participants at risk Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 10 mg of BMS-986278 twice per day during the Optional Treatment Extension (OTE) phase only.	IPF Cohort - OTE Phase - PBO BMS-986278 30 mg n=100 participants at risk Participants who received placebo treatment in the Main Study and received 30 mg of BMS-986278 in the Optional Treatment Extension (OTE)	IPF Cohort - OTE Phase - PBO BMS-986278 60mg n=102 participants at risk Participants who received placebo treatment in the Main Study and received 60 mg of BMS-986278 in the Optional Treatment Extension (OTE)	PF-ILD Cohort - Main Study - Placebo n=41 participants at risk Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort - Main Study - BMS-986278 30mg n=40 participants at risk Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort - Main Study - BMS-986278 60mg n=42 participants at risk Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort - OTE Phase - BMS-986278 10mg n=4 participants at risk Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 10 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase only.	PF-ILD Cohort - OTE Phase - PBO BMS-986278 30mg n=41 participants at risk Participants who received placebo treatment in the Main Study and received 30 mg of BMS-986278 in the Optional Treatment Extension (OTE)	PF-ILD Cohort - OTE Phase - PBO BMS-986278 60mg n=46 participants at risk Participants who received placebo treatment in the Main Study and received 60 mg of BMS-986278 in the Optional Treatment Extension (OTE)
Blood and lymphatic system disorders Anaemia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Eye disorders Cataract	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Cardiac disorders Acute myocardial infarction	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Cardiac disorders Atrial fibrillation	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Cardiac disorders Atrial flutter	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Cardiac disorders Cardiac failure	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Cardiac disorders Cardiac tamponade	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Cardiac disorders Coronary artery disease	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Cardiac disorders Myocardial infarction	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Cardiac disorders Pericardial effusion	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Cardiac disorders Pericarditis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Ear and labyrinth disorders Vertigo positional	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Anal fistula	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Colitis ischaemic	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Diarrhoea	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Haematemesis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Hiatus hernia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Inguinal hernia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Inguinal hernia, obstructive	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Pancreatitis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
General disorders Asthenia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Hepatobiliary disorders Bile duct stone	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Hepatobiliary disorders Cholangitis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Hepatobiliary disorders Cholecystitis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Bronchitis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Bronchitis bacterial	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations COVID-19	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations COVID-19 pneumonia	2.2% 2/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Clostridium difficile infection	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Diabetic foot infection	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Herpes zoster	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Lower respiratory tract infection	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Pneumonia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.0% 2/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Pneumonia legionella	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Respiratory tract infection	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Upper respiratory tract infection	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Urinary tract infection	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Injury, poisoning and procedural complications Animal bite	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Injury, poisoning and procedural complications Fall	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Investigations Forced vital capacity decreased	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Investigations Weight decreased	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Metabolism and nutrition disorders Fluid retention	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Musculoskeletal and connective tissue disorders Back pain	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.9% 3/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage I	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Nervous system disorders Cerebrovascular accident	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Nervous system disorders Peripheral motor neuropathy	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Nervous system disorders Sciatic nerve palsy	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Nervous system disorders Syncope	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Renal and urinary disorders Calculus urinary	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Renal and urinary disorders Urinary retention	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Reproductive system and breast disorders Scrotal dermatitis	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.0% 2/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Hypersensitivity pneumonitis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Idiopathic interstitial pneumonia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	3.3% 3/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.4% 4/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	8.0% 8/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	6.9% 7/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.9% 2/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Lung opacity	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Vascular disorders Granulomatosis with polyangiitis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Vascular disorders Vasculitis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).

Other adverse events

Other adverse events
Measure	IPF Cohort - Main Study - Placebo n=92 participants at risk Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.	IPF Cohort - Main Study - 30 mg BMS-986278 n=91 participants at risk Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	IPF Cohort - Main Study - BMS-986278 60mg n=93 participants at risk Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.	IPF Cohort - BMS-986278 10mg n=11 participants at risk Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 10 mg of BMS-986278 twice per day during the Optional Treatment Extension (OTE) phase only.	IPF Cohort - OTE Phase - PBO BMS-986278 30 mg n=100 participants at risk Participants who received placebo treatment in the Main Study and received 30 mg of BMS-986278 in the Optional Treatment Extension (OTE)	IPF Cohort - OTE Phase - PBO BMS-986278 60mg n=102 participants at risk Participants who received placebo treatment in the Main Study and received 60 mg of BMS-986278 in the Optional Treatment Extension (OTE)	PF-ILD Cohort - Main Study - Placebo n=41 participants at risk Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.	PF-ILD Cohort - Main Study - BMS-986278 30mg n=40 participants at risk Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.	PF-ILD Cohort - Main Study - BMS-986278 60mg n=42 participants at risk Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 60 mg BMS-986278 twice per day for up to 26 weeks.	PF-ILD Cohort - OTE Phase - BMS-986278 10mg n=4 participants at risk Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 10 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase only.	PF-ILD Cohort - OTE Phase - PBO BMS-986278 30mg n=41 participants at risk Participants who received placebo treatment in the Main Study and received 30 mg of BMS-986278 in the Optional Treatment Extension (OTE)	PF-ILD Cohort - OTE Phase - PBO BMS-986278 60mg n=46 participants at risk Participants who received placebo treatment in the Main Study and received 60 mg of BMS-986278 in the Optional Treatment Extension (OTE)
Cardiac disorders Supraventricular extrasystoles	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Eye disorders Cataract	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	6.5% 3/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Constipation	5.4% 5/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	5.4% 5/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.0% 2/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.0% 2/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.8% 2/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.3% 2/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Dental caries	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	25.0% 1/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Diarrhoea	13.0% 12/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	11.0% 10/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	11.8% 11/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.0% 4/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.8% 8/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	14.6% 6/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	15.0% 6/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.1% 3/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.9% 2/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Nausea	3.3% 3/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	5.5% 5/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.3% 4/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.3% 3/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	10.0% 4/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Gastrointestinal disorders Vomiting	4.3% 4/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 2/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.5% 3/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
General disorders Asthenia	2.2% 2/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 2/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.3% 2/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
General disorders Fatigue	4.3% 4/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	5.5% 5/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.0% 2/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.9% 4/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.1% 3/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	25.0% 1/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Bronchitis	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.4% 4/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.0% 4/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.9% 5/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.9% 2/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	25.0% 1/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.9% 2/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	6.5% 3/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations COVID-19	7.6% 7/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.3% 3/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.7% 9/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	12.0% 12/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.8% 8/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.9% 2/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	12.5% 5/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	14.3% 6/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	25.0% 1/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	17.1% 7/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	13.0% 6/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Herpes zoster	2.2% 2/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	5.0% 2/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Influenza	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	25.0% 1/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Laryngitis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Nasopharyngitis	2.2% 2/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	6.6% 6/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.2% 3/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.0% 3/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.1% 3/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Upper respiratory tract infection	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.3% 3/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.9% 3/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.1% 3/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	25.0% 1/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Infections and infestations Viral upper respiratory tract infection	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	5.0% 2/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Investigations Blood bilirubin increased	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	25.0% 1/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Metabolism and nutrition disorders Decreased appetite	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.3% 4/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	25.0% 1/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Musculoskeletal and connective tissue disorders Arthralgia	5.4% 5/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.4% 4/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.3% 4/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.0% 3/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.8% 2/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	25.0% 1/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.3% 2/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Musculoskeletal and connective tissue disorders Back pain	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.4% 4/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.2% 3/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.9% 3/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.8% 2/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	25.0% 1/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Nervous system disorders Dizziness	3.3% 3/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 2/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 2/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.8% 4/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.5% 4/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.3% 2/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Nervous system disorders Dizziness exertional	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Nervous system disorders Headache	3.3% 3/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	6.6% 6/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	5.4% 5/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.0% 3/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.9% 4/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.3% 3/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.5% 1/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.8% 2/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.9% 2/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Cough	5.4% 5/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	6.6% 6/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	10.8% 10/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.0% 3/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	6.9% 7/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.8% 4/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.5% 3/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	11.9% 5/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	25.0% 1/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.3% 3/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.3% 2/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.7% 8/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.4% 4/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.3% 4/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.0% 3/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	5.9% 6/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	14.6% 6/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	5.0% 2/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.9% 2/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	2.2% 2/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.3% 3/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 2/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.0% 3/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	5.9% 6/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 2/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.1% 3/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 2/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.0% 1/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Skin and subcutaneous tissue disorders Rash	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 2/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 2/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.5% 3/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	1.1% 1/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Vascular disorders Deep vein thrombosis	0.00% 0/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Vascular disorders Hypertension	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.3% 3/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.5% 7/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.0% 3/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.98% 1/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Vascular disorders Hypotension	1.1% 1/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 2/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.3% 4/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.9% 3/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	10.0% 4/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.1% 3/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Vascular disorders Orthostatic hypotension	9.8% 9/92 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	7.7% 7/91 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	5.4% 5/93 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	3.0% 3/100 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/102 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.4% 1/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	5.0% 2/40 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	9.5% 4/42 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	0.00% 0/4 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	4.9% 2/41 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).	2.2% 1/46 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

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