Trial Outcomes & Findings for An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy (NCT NCT02538666)

Last Updated: 2023-01-05

Results Overview

OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

907 participants

Primary outcome timeframe

From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)

Results posted on

2023-01-05

Participant Flow

907 participants were randomized and 903 were treated. 2 participants were in both the Global and China population.

Participant milestones

Participant milestones
Measure	Placebo 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Nivolumab 240 mg Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks
Pre-Treatment STARTED	300	304	303
Pre-Treatment Global	275	280	279
Pre-Treatment China	26	25	24
Pre-Treatment COMPLETED	298	303	302
Pre-Treatment NOT COMPLETED	2	1	1
Treatment STARTED	298	303	302
Treatment Global	273	279	278
Treatment China	26	25	24
Treatment COMPLETED	0	0	0
Treatment NOT COMPLETED	298	303	302

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Nivolumab 240 mg Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks
Pre-Treatment Disease progression	1	0	0
Pre-Treatment no longer meets study criteria	1	0	0
Pre-Treatment Withdrew Consent	0	1	1
Treatment Disease progression	270	227	165
Treatment Study drug toxicity	1	29	92
Treatment Death	0	2	3
Treatment Adverse event unrelated to study drug	8	10	15
Treatment Participant request to discontinue study treatment	3	6	11
Treatment Participant withdrew consent	2	5	3
Treatment Lost to Follow-up	0	1	1
Treatment Maximum clinical benefit	4	3	4
Treatment Poor/non-compliance	0	1	0
Treatment Participant no longer meets study criteria	0	2	0
Treatment Administrative reason by sponsor	0	0	1
Treatment Other reasons	8	15	5
Treatment Not reported	2	2	2

Baseline Characteristics

An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=300 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Nivolumab 240 mg n=304 Participants Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=303 Participants Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks	Total n=907 Participants Total of all reporting groups
Age, Customized < 65	161 Participants n=39 Participants	149 Participants n=41 Participants	152 Participants n=35 Participants	462 Participants n=31 Participants
Age, Customized ≥ 65 and < 75	113 Participants n=39 Participants	120 Participants n=41 Participants	115 Participants n=35 Participants	348 Participants n=31 Participants
Age, Customized ≥ 75 and < 85	26 Participants n=39 Participants	35 Participants n=41 Participants	35 Participants n=35 Participants	96 Participants n=31 Participants
Age, Customized ≥ 85	0 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants	1 Participants n=31 Participants
Sex: Female, Male Female	103 Participants n=39 Participants	105 Participants n=41 Participants	101 Participants n=35 Participants	309 Participants n=31 Participants
Sex: Female, Male Male	197 Participants n=39 Participants	199 Participants n=41 Participants	202 Participants n=35 Participants	598 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=39 Participants	11 Participants n=41 Participants	15 Participants n=35 Participants	40 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	160 Participants n=39 Participants	164 Participants n=41 Participants	171 Participants n=35 Participants	495 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	126 Participants n=39 Participants	129 Participants n=41 Participants	117 Participants n=35 Participants	372 Participants n=31 Participants
Race/Ethnicity, Customized Asian	94 Participants n=39 Participants	82 Participants n=41 Participants	82 Participants n=35 Participants	258 Participants n=31 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=39 Participants	6 Participants n=41 Participants	1 Participants n=35 Participants	9 Participants n=31 Participants
Race/Ethnicity, Customized White	198 Participants n=39 Participants	213 Participants n=41 Participants	216 Participants n=35 Participants	627 Participants n=31 Participants
Race/Ethnicity, Customized Other	6 Participants n=39 Participants	3 Participants n=41 Participants	3 Participants n=35 Participants	12 Participants n=31 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants	1 Participants n=31 Participants

PRIMARY outcome

Timeframe: From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)

Population: All randomized participants in the nivolumab + ipilimumab and placebo arms in the global population

Outcome measures

Outcome measures
Measure	Global Placebo n=275 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=279 Participants Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks	China Placebo 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion	China Nivolumab 240 mg Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 240 mg Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population	9.56 Months Interval 8.18 to 11.01	9.17 Months Interval 8.15 to 10.25	—	—	—	—

SECONDARY outcome

Timeframe: From randomization to the date of death or last known alive date (up to approximately 73 months)

Population: All randomized participants in the nivolumab monotherapy and placebo arms

Overall Survival (OS) comparing nivolumab monotherapy versus placebo. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.

Outcome measures

Outcome measures
Measure	Global Placebo n=275 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=280 Participants Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks	China Placebo n=26 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion	China Nivolumab 240 mg n=25 Participants Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 240 mg Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks
Overall Survival (OS) of Nivolumab Versus Placebo	9.56 Months Interval 8.18 to 11.01	10.18 Months Interval 9.43 to 11.99	9.28 Months Interval 5.59 to 14.26	8.18 Months Interval 7.2 to 14.26	—	—

SECONDARY outcome

Timeframe: From randomization to the date of death or last known alive date (up to approximately 73 months)

Population: All randomized participants in the Nivolumab + Ipilimumab and Nivolumab arms

Overall Survival (OS) comparing Nivolumab + Ipilimumab Versus Nivolumab. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.

Outcome measures

Outcome measures
Measure	Global Placebo n=280 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=279 Participants Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks	China Placebo n=25 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion	China Nivolumab 240 mg n=24 Participants Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 240 mg Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab	10.18 Months Interval 9.43 to 11.99	9.17 Months Interval 8.15 to 10.35	8.18 Months Interval 7.2 to 14.26	10.48 Months Interval 7.13 to 13.4	—	—

SECONDARY outcome

Timeframe: From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)

Population: All randomized participants

PFS was defined as the time between the date of randomization and the first date of documented progression as determined by Blind Independent Central Review (BICR) or death due to any cause, whichever occurred first. Participants who died with no reported progression were considered to have progressed on the date of death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on study tumor assessments and did not die (or died after initiation of the subsequent anti- cancer therapy) were censored on their date of randomization. Participants who started any subsequent anti- cancer therapy without a prior reported Progressive Disease (PD) per BICR were censored at the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.

Outcome measures

Outcome measures
Measure	Global Placebo n=275 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=280 Participants Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks	China Placebo n=279 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion	China Nivolumab 240 mg n=26 Participants Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 240 mg n=25 Participants Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=24 Participants Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks
Progression Free Survival (PFS) Per BICR	1.41 Months Interval 1.41 to 1.48	1.94 Months Interval 1.61 to 2.63	1.74 Months Interval 1.48 to 2.63	1.38 Months Interval 1.28 to 2.56	1.58 Months Interval 1.38 to 4.11	1.54 Months Interval 1.28 to 2.73

SECONDARY outcome

Timeframe: From randomization to the date of death or last known alive date (up to approximately 73 months)

Population: All TMB evaluable participants in the global population

Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined. OS in TMB by the following cutoff points: ≥10 mutations/mb, \< 10 mutations/mb, ≥13 mutations/mb, \<13 mutations/mb

Outcome measures

Outcome measures
Measure	Global Placebo n=192 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=196 Participants Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks	China Placebo n=192 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion	China Nivolumab 240 mg Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 240 mg Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks
Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population ≥10 mutations/mb	11.96 Months Interval 7.49 to 13.67	12.81 Months Interval 9.95 to 18.6	10.55 Months Interval 8.38 to 14.16	—	—	—
Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population <13 mutations/mb	10.02 Months Interval 7.66 to 11.47	9.89 Months Interval 8.64 to 11.3	7.85 Months Interval 6.67 to 9.66	—	—	—
Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population < 10 mutations/mb	9.20 Months Interval 7.46 to 11.04	9.76 Months Interval 8.34 to 11.3	8.11 Months Interval 6.6 to 10.05	—	—	—
Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population ≥13 mutations/mb	9.69 Months Interval 6.21 to 13.63	12.98 Months Interval 9.95 to 18.6	13.47 Months Interval 9.26 to 21.75	—	—	—

SECONDARY outcome

Timeframe: From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)

Population: All TMB evaluable participants in the global population

Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined. PFS in TMB by the following cutoff points: ≥10 mutations/mb, \< 10 mutations/mb, ≥13 mutations/mb, \<13 mutations/mb.

Outcome measures

Outcome measures
Measure	Global Placebo n=192 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=196 Participants Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks	China Placebo n=192 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion	China Nivolumab 240 mg Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 240 mg Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks
Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population ≥10 mutations/mb	1.58 Months Interval 1.41 to 2.63	2.79 Months Interval 2.04 to 4.17	2.33 Months Interval 1.48 to 2.92	—	—	—
Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population < 10 mutations/mb	1.41 Months Interval 1.35 to 1.45	1.61 Months Interval 1.45 to 2.53	1.48 Months Interval 1.41 to 2.0	—	—	—
Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population ≥13 mutations/mb	1.58 Months Interval 1.41 to 2.63	2.76 Months Interval 1.61 to 4.11	2.63 Months Interval 1.48 to 3.81	—	—	—
Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population <13 mutations/mb	1.41 Months Interval 1.38 to 1.45	1.84 Months Interval 1.48 to 2.66	1.48 Months Interval 1.41 to 2.0	—	—	—

POST_HOC outcome

Timeframe: From randomization to the date of death or last known alive date (up to approximately 73 months)

Population: All randomized participants in the nivolumab + ipilimumab and placebo arms

Overall survival (OS) comparing nivolumab + ipilimumab versus placebo. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 11-Nov-2021).

Outcome measures

Outcome measures
Measure	Global Placebo n=275 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=279 Participants Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks	China Placebo n=26 Participants 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion	China Nivolumab 240 mg n=24 Participants Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 240 mg Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo - Extended Collection	9.56 Months Interval 8.18 to 11.01	9.17 Months Interval 8.15 to 10.35	9.28 Months Interval 5.59 to 14.26	10.48 Months Interval 7.13 to 13.4	—	—

Adverse Events

Global Placebo

Serious events: 117 serious events

Other events: 228 other events

Deaths: 250 deaths

Global Nivolumab 240 mg

Serious events: 131 serious events

Other events: 244 other events

Deaths: 231 deaths

Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg

Serious events: 198 serious events

Other events: 263 other events

Deaths: 240 deaths

China Placebo

Serious events: 8 serious events

Other events: 22 other events

Deaths: 24 deaths

China Nivolumab 240 mg

Serious events: 10 serious events

Other events: 23 other events

Deaths: 23 deaths

China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg

Serious events: 19 serious events

Other events: 24 other events

Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure	Global Placebo n=273 participants at risk 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Global Nivolumab 240 mg n=279 participants at risk Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=278 participants at risk Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks	China Placebo n=26 participants at risk 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion	China Nivolumab 240 mg n=25 participants at risk Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=24 participants at risk Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks
Blood and lymphatic system disorders Anaemia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Febrile neutropenia	2.6% 7/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.5% 7/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Myelosuppression	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Acute myocardial infarction	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Angina unstable	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Atrial flutter	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiac failure	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiac failure acute	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Coronary artery disease	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Myocardial infarction	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Myocarditis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Pericardial effusion	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Sinus tachycardia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Ear and labyrinth disorders Vertigo positional	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Adrenal insufficiency	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.4% 4/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Adrenocortical insufficiency acute	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Cushing's syndrome	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hyperthyroidism	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hypopituitarism	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hypothyroidism	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Immune-mediated adrenal insufficiency	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Immune-mediated hyperthyroidism	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Eye disorders Cataract	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Eye disorders Eyelid ptosis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Eye disorders Iridocyclitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Eye disorders Papilloedema	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Eye disorders Rhegmatogenous retinal detachment	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Eye disorders Vision blurred	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Anal fistula	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Colitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	6.8% 19/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.8% 16/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Dysphagia	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Enteritis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Enterocolitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Haematemesis	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Inguinal hernia	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Intestinal infarction	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Intestinal perforation	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Pancreatic mass	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Pancreatitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Pancreatitis acute	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Proctitis ulcerative	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Stomatitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	1.1% 3/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.8% 5/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Asthenia	1.1% 3/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.2% 6/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Chest discomfort	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Chest pain	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Death	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Facial pain	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Fatigue	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.5% 7/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders General physical health deterioration	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.8% 5/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Influenza like illness	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Mucosal inflammation	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Non-cardiac chest pain	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Pain	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Performance status decreased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Pyrexia	1.5% 4/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.9% 8/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Sudden death	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Drug-induced liver injury	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Hepatic failure	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Hepatitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.4% 4/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Liver injury	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Immune system disorders Anaphylactic shock	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Abdominal abscess	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Anal abscess	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Bacterial diarrhoea	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Bronchitis	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Cellulitis	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Clostridium difficile colitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Clostridium difficile infection	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Cytomegalovirus enteritis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Diverticulitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Encephalitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Gastric infection	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Gastrointestinal infection	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Herpes simplex	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Herpes zoster	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Infective thrombosis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Influenza	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Lower respiratory tract infection	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Neutropenic infection	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Neutropenic sepsis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Osteomyelitis	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Periodontitis	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumocystis jirovecii pneumonia	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia	3.3% 9/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.2% 6/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.3% 12/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia aspiration	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia legionella	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pulmonary sepsis	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Respiratory tract infection	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Sepsis	1.1% 3/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.9% 8/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Septic shock	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Soft tissue infection	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Staphylococcal infection	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Toxic shock syndrome	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Vascular device infection	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Fall	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Femur fracture	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Fracture	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Hip fracture	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Radiation pneumonitis	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Tendon rupture	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Amylase increased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Blood glucose increased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations General physical condition abnormal	1.1% 3/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Hepatic enzyme increased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Lipase increased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Neutrophil count decreased	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Platelet count decreased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Transaminases increased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations White blood cell count decreased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Appetite disorder	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Decreased appetite	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Dehydration	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.2% 6/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Failure to thrive	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	1.8% 5/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.5% 7/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.2% 9/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	1.1% 3/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Spinal disorder	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Spinal pain	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	18.3% 50/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	17.9% 50/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	18.3% 51/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	15.4% 4/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spinal cord	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.4% 4/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Cauda equina syndrome	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Cerebral infarction	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Cognitive disorder	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Dizziness	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Dysarthria	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Encephalitis autoimmune	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Encephalopathy	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Epilepsy	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Haemorrhage intracranial	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Hemiparesis	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Immune-mediated encephalitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Ischaemic stroke	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Lethargy	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Limbic encephalitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Metabolic encephalopathy	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Myasthenia gravis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Myelopathy	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Neurological decompensation	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Neurological symptom	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Occipital neuralgia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Paraesthesia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Paraparesis	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Partial seizures	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Seizure	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Spinal cord compression	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Status epilepticus	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Syncope	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Toxic encephalopathy	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Transient ischaemic attack	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Tremor	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Confusional state	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Delirium	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Insomnia	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Mental status changes	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Acute kidney injury	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Bladder mass	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Immune-mediated cystitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Renal failure	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Renal tubular disorder	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Autoimmune lung disease	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Bronchial haemorrhage	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.8% 5/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.8% 5/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.2% 9/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.4% 4/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Hypersensitivity pneumonitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.9% 8/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.0% 14/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Productive cough	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Skin toxicity	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Vascular disorders Circulatory collapse	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Vascular disorders Deep vein thrombosis	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Vascular disorders Embolism	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypertension	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypotension	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Vascular disorders Shock	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Vascular disorders Superior vena cava stenosis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Vascular disorders Superior vena cava syndrome	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.4% 4/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Vascular disorders Venous thrombosis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.

Other adverse events

Other adverse events
Measure	Global Placebo n=273 participants at risk 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion	Global Nivolumab 240 mg n=279 participants at risk Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=278 participants at risk Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks	China Placebo n=26 participants at risk 100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion	China Nivolumab 240 mg n=25 participants at risk Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg n=24 participants at risk Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks
Blood and lymphatic system disorders Anaemia	11.4% 31/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	10.8% 30/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	9.0% 25/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	38.5% 10/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.0% 4/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	50.0% 12/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Leukopenia	1.5% 4/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.2% 6/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	11.5% 3/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Neutropenia	1.8% 5/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.9% 8/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.2% 6/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	2.6% 7/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.4% 4/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.6% 10/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	20.8% 5/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Sinus tachycardia	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hyperthyroidism	2.2% 6/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	6.5% 18/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	10.1% 28/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hypothyroidism	1.1% 3/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.2% 23/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	10.8% 30/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	20.8% 5/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal distension	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	4.8% 13/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.7% 16/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.9% 22/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain upper	5.1% 14/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.6% 10/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 11/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	13.6% 37/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.2% 34/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	18.3% 51/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.7% 4/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	17.2% 47/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	21.1% 59/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	31.7% 88/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.7% 4/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Mouth ulceration	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	24.5% 67/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	24.7% 69/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	28.1% 78/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	11.5% 3/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.0% 3/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.7% 4/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Toothache	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	7.7% 21/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	9.7% 27/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.9% 47/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	11.5% 3/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Asthenia	13.2% 36/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	14.0% 39/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.2% 45/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.0% 3/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Chest discomfort	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Chest pain	2.9% 8/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.6% 10/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.2% 9/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Fatigue	24.2% 66/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	31.5% 88/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	30.9% 86/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	29.2% 7/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Malaise	2.6% 7/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.2% 6/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.2% 9/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	29.2% 7/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Non-cardiac chest pain	6.2% 17/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.6% 10/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 11/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	11.5% 3/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Oedema peripheral	5.5% 15/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.7% 16/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	6.5% 18/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Pain	1.1% 3/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.5% 7/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.8% 5/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
General disorders Pyrexia	4.0% 11/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.2% 20/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	15.5% 43/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	15.4% 4/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.0% 3/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	25.0% 6/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Liver injury	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Influenza	1.1% 3/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.8% 5/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pharyngitis	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia	2.2% 6/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.4% 15/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.0% 14/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	1.5% 4/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.7% 13/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.0% 14/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	11.5% 3/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	2.9% 8/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.5% 7/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.5% 7/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Alanine aminotransferase increased	4.4% 12/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.5% 21/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	15.5% 43/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	15.4% 4/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	24.0% 6/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	45.8% 11/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Amylase increased	3.3% 9/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.2% 9/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	6.8% 19/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.0% 3/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Aspartate aminotransferase increased	3.7% 10/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	6.8% 19/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	14.0% 39/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	11.5% 3/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	28.0% 7/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	41.7% 10/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Bilirubin conjugated increased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Blood albumin decreased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.7% 4/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Blood alkaline phosphatase increased	1.8% 5/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.6% 10/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.3% 12/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Blood bilirubin increased	1.1% 3/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.72% 2/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.1% 3/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	20.8% 5/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Blood creatine phosphokinase increased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Blood creatinine increased	3.3% 9/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.9% 11/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	6.8% 19/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Blood sodium decreased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Blood urea increased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Gamma-glutamyltransferase increased	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.4% 4/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.9% 8/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.0% 3/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Lipase increased	4.0% 11/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.3% 12/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	10.1% 28/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Neutrophil count decreased	5.5% 15/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.9% 11/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.6% 10/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	30.8% 8/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.0% 4/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.7% 4/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Platelet count decreased	1.8% 5/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.3% 12/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.0% 14/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	11.5% 3/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	20.0% 5/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Thyroxine free decreased	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations Weight decreased	4.4% 12/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.7% 16/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	9.7% 27/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	25.0% 6/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Investigations White blood cell count decreased	2.6% 7/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.9% 8/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.2% 6/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	26.9% 7/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Decreased appetite	20.9% 57/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	25.4% 71/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	36.3% 101/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	30.8% 8/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	28.0% 7/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	37.5% 9/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Dehydration	2.6% 7/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.6% 10/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	6.1% 17/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	4.8% 13/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.7% 13/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	6.8% 19/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.0% 3/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperuricaemia	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.8% 5/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.2% 9/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoalbuminaemia	0.37% 1/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.8% 5/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.9% 8/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 3/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	2.6% 7/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.9% 11/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.2% 20/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.7% 4/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypomagnesaemia	3.3% 9/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.9% 11/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.4% 15/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	5.5% 15/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.9% 22/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.6% 35/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.0% 4/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	20.8% 5/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 26/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	12.5% 35/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	11.2% 31/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.7% 4/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	8.1% 22/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	10.8% 30/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.9% 22/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	2.6% 7/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.9% 8/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.7% 13/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 16/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	9.3% 26/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.9% 22/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Dizziness	8.8% 24/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	10.4% 29/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	10.1% 28/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Headache	9.9% 27/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	13.3% 37/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	17.6% 49/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.8% 1/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Insomnia	5.9% 16/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	6.8% 19/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	9.0% 25/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.36% 1/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	20.1% 55/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	19.7% 55/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	19.1% 53/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	38.5% 10/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	24.0% 6/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	45.8% 11/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.7% 40/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	22.9% 64/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	17.6% 49/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.7% 2/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.2% 1/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.9% 8/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.5% 7/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	1.4% 4/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	11.5% 3/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Productive cough	4.0% 11/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.4% 15/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.7% 13/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	19.2% 5/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	25.0% 6/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dry skin	5.5% 15/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.9% 11/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	6.5% 18/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Erythema	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.2% 6/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.5% 7/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	4.0% 1/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	11.4% 31/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	15.4% 43/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	28.8% 80/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	29.2% 7/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash	5.9% 16/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	7.2% 20/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	24.5% 68/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.0% 2/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	16.7% 4/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.3% 9/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	3.6% 10/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	9.4% 26/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	8.3% 2/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypotension	0.73% 2/273 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	2.5% 7/279 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	5.0% 14/278 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/26 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/25 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.	0.00% 0/24 • Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months). The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.

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
Publication restrictions are in place

Restriction type: LTE60