Trial Outcomes & Findings for A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma (NCT NCT02996110)

NCT ID: NCT02996110

Last Updated: 2022-12-19

Results Overview

ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 182 participants
• Primary outcome timeframe: From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)
• Results posted on: 2022-12-19

Participant Flow

Of the 178 participants that were treated, 60 were initially randomized to Track 1 and 118 were initially randomized to Track 2. The 152 participants that started treatment in Track 2 include the total number of participants that received treatment in each arm which incorporates the 35 participants from Track 1 or 2 that were re-randomized to receive a different treatment combination in Track 2.

Participant milestones

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Pre-Treatment STARTED	65	56	26	17	18
Pre-Treatment COMPLETED	65	55	25	17	16
Pre-Treatment NOT COMPLETED	0	1	1	0	2
Track 1 STARTED	30	30	0	0	0
Track 1 Re-Randomized to Track 2	5	6	0	0	0
Track 1 COMPLETED	7	8	0	0	0
Track 1 NOT COMPLETED	23	22	0	0	0
Track 2 STARTED	46	32	31	21	22
Track 2 No Pre-Randomization	35	25	25	17	16
Track 2 Re-Randomized From Track 1 Nivolumab + Relatlimab	2	0	2	1	1
Track 2 Re-Randomized From Track 1 Nivolumab + Ipilimumab	0	3	1	1	0
Track 2 Re-Randomized From Track 2 Nivolumab + Relatlimab	7	0	2	0	1
Track 2 Re-Randomized From Track 2 Nivolumab + BMS986205	2	2	0	1	2
Track 2 Previously Un-Treated But Re-Randomized	0	0	0	1	0
Track 2 Re-Randomized From Track 2 Nivolumab + Ipilimumab	0	2	1	0	2
Track 2 COMPLETED	4	3	1	1	1
Track 2 NOT COMPLETED	42	29	30	20	21

Reasons for withdrawal

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Pre-Treatment Other Reasons	0	1	0	0	1
Pre-Treatment Participant Withdrew Consent	0	0	1	0	1
Track 1 Disease Progression	15	17	0	0	0
Track 1 Adverse Event Unrelated to Study Drug	1	1	0	0	0
Track 1 Study Drug Toxicity	5	3	0	0	0
Track 1 Participant Requested to Discontinue Study Treatment	1	0	0	0	0
Track 1 Administrative Reason by Sponsor	0	1	0	0	0
Track 1 Participant no Longer Met Study Criteria	1	0	0	0	0
Track 2 Disease Progression	33	26	19	16	15
Track 2 Adverse Event Unrelated to Study Drug	4	0	0	1	1
Track 2 Death	0	0	1	0	1
Track 2 Study Drug Toxicity	4	1	4	1	0
Track 2 Participant Requested to Discontinue Study Treatment	0	0	2	1	2
Track 2 Participant Withdrew Consent	1	2	3	1	1
Track 2 Other Reasons	0	0	1	0	1

Baseline Characteristics

The analysis population consists of all participants treated (including those re-randomized) in each Arm.

Baseline characteristics by cohort

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=65 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=56 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 n=26 Participants Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg n=17 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg n=18 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Total n=182 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	41 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	16 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	12 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	11 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	120 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Age, Categorical >=65 years	25 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	15 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	10 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	5 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	7 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	62 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Sex: Female, Male Female	14 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	16 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	6 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	4 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	9 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	49 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Sex: Female, Male Male	51 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	40 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	20 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	13 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	9 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	133 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Ethnicity (NIH/OMB) Track 2 · Hispanic or Latino	3 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	2 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	2 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	1 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	8 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Ethnicity (NIH/OMB) Track 2 · Not Hispanic or Latino	37 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	34 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	19 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	12 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	10 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	112 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Ethnicity (NIH/OMB) Track 2 · Unknown or Not Reported	25 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	20 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	5 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	4 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	8 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	62 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Race/Ethnicity, Customized White	62 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	52 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	23 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	14 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	17 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	168 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Race/Ethnicity, Customized Asian Indian	1 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	1 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Race/Ethnicity, Customized Chinese	0 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	1 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	1 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Race/Ethnicity, Customized Asian Other	1 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	1 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	2 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Race/Ethnicity, Customized Other	1 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	2 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	2 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	2 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	7 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	0 Participants n=7 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	1 Participants n=5 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	1 Participants n=4 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	1 Participants n=21 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.	3 Participants n=10 Participants • The analysis population consists of all participants treated (including those re-randomized) in each Arm.

PRIMARY outcome

Timeframe: From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)

Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.

ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR).

BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first.

For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy.

CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm.

PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment.

CR+PR, confidence interval based on Clopper and Pearson method.

Outcome measures

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=76 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=62 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 n=31 Participants Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg n=21 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg n=22 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Objective Response Rate (ORR) Per Investigator Track 1	20 Percent of participants Interval 7.7 to 38.6	30 Percent of participants Interval 14.7 to 49.4	—	—	—
Objective Response Rate (ORR) Per Investigator Track 2	17.4 Percent of participants Interval 7.8 to 31.4	3.1 Percent of participants Interval 0.1 to 16.2	3.2 Percent of participants Interval 0.1 to 16.7	9.5 Percent of participants Interval 1.2 to 30.4	0.0 Percent of participants Interval 0.0 to 15.4

PRIMARY outcome

Timeframe: From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks)

Population: All treated participants with a best overall response of CR or PR. Some participants were re-randomized to receive multiple treatment options during the course of the study.

Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first.

Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Median computed using Kaplan -Meier method

Outcome measures

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=14 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=10 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 n=1 Participants Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg n=2 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Median Duration of Response (DOR) Per Investigator Track 1	NA Weeks Interval 33.4 to 139.9 Insufficient number of participants with events. Five of the 6 participants received subsequent therapy prior to progression or death, thus their DOR was censored at the last tumor assessment.	32.57 Weeks Interval 0.1 to 52.6	—	—	—
Median Duration of Response (DOR) Per Investigator Track 2	68.00 Weeks Interval 0.1 to 117.6	99.4 Weeks Interval 99.4 to 99.4	NA Weeks Insufficient number of participants with events	NA Weeks Insufficient number of participants with events	—

PRIMARY outcome

Timeframe: 24 weeks after first treatment dose.

Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.

The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.

Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula

Outcome measures

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=76 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=62 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 n=31 Participants Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg n=21 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg n=22 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Progression Free Survival Rate (PFSR) at 24 Weeks. Track 1	0.491 Proportion of participants Interval 0.294 to 0.661	0.429 Proportion of participants Interval 0.246 to 0.6	—	—	—
Progression Free Survival Rate (PFSR) at 24 Weeks. Track 2	0.432 Proportion of participants Interval 0.277 to 0.577	0.194 Proportion of participants Interval 0.079 to 0.346	0.278 Proportion of participants Interval 0.118 to 0.464	0.468 Proportion of participants Interval 0.237 to 0.67	NA Proportion of participants Insufficient number of participants with events.

SECONDARY outcome

Timeframe: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)

Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=76 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=62 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 n=31 Participants Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg n=21 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg n=22 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Number of Participants With Adverse Events (AEs) Track 1	29 Participants	30 Participants	—	—	—
Number of Participants With Adverse Events (AEs) Track 2	45 Participants	32 Participants	31 Participants	19 Participants	21 Participants

SECONDARY outcome

Timeframe: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)

Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.

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

Outcome measures

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=76 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=62 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 n=31 Participants Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg n=21 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg n=22 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Number of Participants With Serious Adverse Events (SAEs) Track 1	17 Participants	15 Participants	—	—	—
Number of Participants With Serious Adverse Events (SAEs) Track 2	28 Participants	16 Participants	16 Participants	9 Participants	15 Participants

SECONDARY outcome

Timeframe: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)

Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=76 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=62 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 n=31 Participants Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg n=21 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg n=22 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Number of Participants With Adverse Events (AEs) Leading to Discontinuation Track 2	10 Participants	3 Participants	6 Participants	2 Participants	4 Participants
Number of Participants With Adverse Events (AEs) Leading to Discontinuation Track 1	7 Participants	7 Participants	—	—	—

SECONDARY outcome

Timeframe: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)

Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.

Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.

Outcome measures

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=76 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=62 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 n=31 Participants Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg n=21 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg n=22 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Number of Participants Who Died Track 1	12 Participants	15 Participants	—	—	—
Number of Participants Who Died Track 2	27 Participants	17 Participants	13 Participants	10 Participants	13 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)

Population: All treated participants with at least one on-treatment TSH measurement

The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.

Outcome measures

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=28 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=27 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Number of Participants With Abnormal Thyroid Test Results - Track 1 TSH > ULN WITH FT3/FT4 TEST MISSING	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 1 TSH < LLN	10 Participants	5 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 1 TSH > ULN	8 Participants	8 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 1 TSH > ULN WITH TSH <= ULN AT BASELINE	5 Participants	8 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 1 TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN	3 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 1 TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 1 TSH <LLN WITH TSH >= LLN AT BASELINE	9 Participants	5 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 1 TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 1 TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 1 TSH < LLN WITH FT3/FT4 TEST MISSING	5 Participants	4 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)

Population: All treated participants with at Least One On-Treatment TSH measurement. Some participants were re-randomized to receive multiple treatment options during the course of the study.

The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal

Outcome measures

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=42 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=30 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 n=25 Participants Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg n=17 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg n=13 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Number of Participants With Abnormal Thyroid Test Results - Track 2 TSH < LLN	4 Participants	5 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 2 TSH > ULN	14 Participants	14 Participants	6 Participants	3 Participants	4 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 2 TSH > ULN WITH TSH <= ULN AT BASELINE	8 Participants	6 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 2 TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN	5 Participants	3 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 2 TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN	5 Participants	4 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 2 TSH > ULN WITH FT3/FT4 TEST MISSING	4 Participants	7 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 2 TSH <LLN WITH TSH >= LLN AT BASELINE	2 Participants	4 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 2 TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 2 TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Thyroid Test Results - Track 2 TSH < LLN WITH FT3/FT4 TEST MISSING	3 Participants	2 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)

Population: All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement

The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal

Outcome measures

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=28 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=30 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Number of Participants With Abnormal Hepatic Test Results - Track 1 ALT OR AST > 3XULN	2 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 1 ALT OR AST> 5XULN	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 1 ALT OR AST> 10XULN	0 Participants	0 Participants	00 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 1 ALT OR AST > 20XULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 1 TOTAL BILIRUBIN > 2XULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 1 ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 1 ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)

Population: All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement. Some participants were re-randomized to receive multiple treatment options during the course of the study.

The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal

Outcome measures

Measure	Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) n=44 Participants Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 2: Nivolumab Plus Relatlimab (BMS-986016) n=32 Participants Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 3: Nivolumab Plus BMS-986205 n=29 Participants Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 4: Nivolumab Plus BMS-813160 150 mg n=17 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Arm 5: Nivolumab Plus BMS-813160 300mg n=18 Participants Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Number of Participants With Abnormal Hepatic Test Results - Track 2 ALT OR AST> 5XULN	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 2 ALT OR AST > 20XULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 2 TOTAL BILIRUBIN > 2XULN	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 2 ALT OR AST > 3XULN	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 2 ALT OR AST> 10XULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 2 ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Results - Track 2 ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Track 1: Nivolumab Plus Ipilimumab (BMS-734016)

Serious events: 17 serious events

Other events: 28 other events

Deaths: 12 deaths

Track 1: Nivolumab Plus Relatlimab (BMS-986016)

Serious events: 15 serious events

Other events: 29 other events

Deaths: 15 deaths

Track 2: Nivolumab Plus Ipilimumab (BMS-734016)

Serious events: 28 serious events

Other events: 42 other events

Deaths: 27 deaths

Track 2: Nivolumab Plus Relatlimab (BMS-986016)

Serious events: 16 serious events

Other events: 31 other events

Deaths: 17 deaths

Track 2: Nivolumab Plus BMS-986205

Serious events: 16 serious events

Other events: 29 other events

Deaths: 13 deaths

Track 2: Nivolumab Plus BMS-813160 150 mg

Serious events: 9 serious events

Other events: 18 other events

Deaths: 10 deaths

Track 2: Nivolumab Plus BMS-813160 300 mg

Serious events: 15 serious events

Other events: 17 other events

Deaths: 13 deaths

Serious adverse events

Measure	Track 1: Nivolumab Plus Ipilimumab (BMS-734016) n=30 participants at risk Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 1: Nivolumab Plus Relatlimab (BMS-986016) n=30 participants at risk Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 2: Nivolumab Plus Ipilimumab (BMS-734016) n=46 participants at risk Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 2: Nivolumab Plus Relatlimab (BMS-986016) n=32 participants at risk Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 2: Nivolumab Plus BMS-986205 n=31 participants at risk Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 2: Nivolumab Plus BMS-813160 150 mg n=21 participants at risk Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 2: Nivolumab Plus BMS-813160 300 mg n=22 participants at risk Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Hepatobiliary disorders Hepatotoxicity	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Anaemia	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Angina pectoris	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Atrial fibrillation	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiac arrest	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiac failure congestive	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Myocarditis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Pericarditis	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Ventricular tachycardia	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Adrenal insufficiency	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Colitis	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Enteritis	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Enterocolitis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Large intestinal obstruction	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Lip swelling	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Oesophagitis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Asthenia	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Fatigue	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Pain	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Pyrexia	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Biliary obstruction	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Cholecystitis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Bronchitis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Cellulitis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Device related infection	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Epididymitis	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia influenzal	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pulmonary sepsis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Sepsis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Sialoadenitis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Sinusitis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urosepsis	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Wound infection	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Amylase increased	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood alkaline phosphatase increased	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood potassium increased	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Lipase increased	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Transaminases increased	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Dehydration	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypercalcaemia	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypocalcaemia	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Autoimmune myositis	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 5/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.0% 6/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.6% 5/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.7% 3/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.2% 4/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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 bone	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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 lung	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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) Metastatic renal cell carcinoma	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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) Prostate cancer	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Aphasia	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Brain oedema	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Dizziness	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Encephalopathy	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Facial paralysis	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Immune-mediated neuropathy	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Neuralgia	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Pyramidal tract syndrome	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Seizure	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Bladder perforation	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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 nephritis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Oliguria	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Renal haematoma	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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 arrest	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Deep vein thrombosis	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Embolism	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Haematoma	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypotension	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Lymphoedema	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Other adverse events

Measure	Track 1: Nivolumab Plus Ipilimumab (BMS-734016) n=30 participants at risk Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 1: Nivolumab Plus Relatlimab (BMS-986016) n=30 participants at risk Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 2: Nivolumab Plus Ipilimumab (BMS-734016) n=46 participants at risk Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 2: Nivolumab Plus Relatlimab (BMS-986016) n=32 participants at risk Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 2: Nivolumab Plus BMS-986205 n=31 participants at risk Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 2: Nivolumab Plus BMS-813160 150 mg n=21 participants at risk Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.	Track 2: Nivolumab Plus BMS-813160 300 mg n=22 participants at risk Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Gastrointestinal disorders Epigastric discomfort	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Headache	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 10/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.9% 5/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 3/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.6% 3/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 3/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Anaemia	26.7% 8/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 5/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	17.4% 8/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.9% 4/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Sinus tachycardia	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Ear and labyrinth disorders Vertigo	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hyperthyroidism	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hypothyroidism	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	20.0% 6/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.7% 3/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Eye disorders Dry eye	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Eye disorders Vision blurred	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.9% 5/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Colitis	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	26.7% 8/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.9% 5/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	37.5% 12/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.4% 6/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	20.0% 6/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	30.0% 9/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	30.4% 14/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	21.9% 7/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.1% 5/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 6/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Dry mouth	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.7% 4/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	33.3% 10/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	23.3% 7/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	30.4% 14/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 8/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.8% 8/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 6/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.2% 4/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Oral pain	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Stomatitis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.0% 6/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.0% 4/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	16.7% 5/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	20.0% 6/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.2% 7/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.4% 6/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Asthenia	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 3/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.7% 3/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Chest discomfort	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Chills	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.7% 4/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Fatigue	30.0% 9/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	43.3% 13/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	32.6% 15/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	34.4% 11/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.8% 8/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 7/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	27.3% 6/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Gait disturbance	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Mucosal inflammation	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Oedema peripheral	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.0% 6/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.1% 5/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Pyrexia	16.7% 5/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.9% 5/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.6% 5/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Bronchitis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Conjunctivitis	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 3/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Gastroenteritis	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.9% 5/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.7% 3/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.7% 4/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.9% 5/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Alanine aminotransferase increased	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.9% 5/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Amylase increased	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 3/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Aspartate aminotransferase increased	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.9% 5/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.7% 3/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 3/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood alkaline phosphatase increased	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood bilirubin increased	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood creatinine increased	16.7% 5/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.7% 3/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Lipase increased	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 3/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Weight decreased	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.9% 5/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	16.7% 5/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 5/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	26.1% 12/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 8/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.9% 4/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	23.8% 5/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.6% 3/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypercalcaemia	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 3/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.7% 3/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 3/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoalbuminaemia	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypomagnesaemia	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypophosphataemia	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	20.0% 6/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.9% 5/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	21.9% 7/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	22.6% 7/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.2% 4/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 5/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.0% 6/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	21.9% 7/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.4% 6/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 3/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.2% 4/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Flank pain	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.0% 6/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.7% 3/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.6% 5/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Neck pain	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.6% 5/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.9% 4/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Amnesia	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Dizziness	16.7% 5/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.0% 6/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 3/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Dizziness postural	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Dysgeusia	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Lethargy	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Paraesthesia	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Taste disorder	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.7% 3/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Tremor	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Anxiety	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Depression	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Insomnia	16.7% 5/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.7% 4/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Dysuria	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 3/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Pollakiuria	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Urinary retention	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	36.7% 11/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	20.0% 6/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	21.7% 10/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 8/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.4% 6/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 6/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dysphonia	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 3/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	23.3% 7/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.0% 6/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	22.6% 7/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.2% 4/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.7% 3/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.3% 4/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 3/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Night sweats	10.0% 3/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	33.3% 10/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	20.0% 6/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	21.7% 10/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 8/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 3/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	26.7% 8/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	23.3% 7/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	26.1% 12/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	21.9% 7/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.7% 3/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.0% 4/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 2/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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	16.7% 5/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 1/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.5% 1/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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 pruritic	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hot flush	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.2% 1/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.5% 2/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypertension	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 2/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.7% 4/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.5% 2/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypotension	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 1/30 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 2/46 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 1/31 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/21 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/22 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events 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: Clinical.Trials@bms.com

Results disclosure agreements

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

Restriction type: OTHER