Trial Outcomes & Findings for A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers (NCT NCT03400332)

NCT ID: NCT03400332

Last Updated: 2025-07-25

Results Overview

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

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE1/PHASE2
• Target enrollment: 281 participants
• Primary outcome timeframe: From first dose up to 100 days after last dose (up to 65 months)
• Results posted on: 2025-07-25

Participant Flow

281 participants were randomized and 278 received treatment. Part 1: 159 participants were directly treated and not blinded (open label). Part 2: 122 participants were double-blinded and randomized. 122 participants were randomized in the pre-treatment phase while 119 received treatment. 3 participants were randomized but did not receive treatment.

Participant milestones

Measure	Part 1: 600 Q4W 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W	Part 2 Arm A: BMS+Nivo+Ipi BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter	Part 2 Arm B: Placebo+Nivo+Ipi Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter
Pre-Treatment STARTED	16	15	18	12	63	20	15	62	60
Pre-Treatment Randomized	0	0	0	0	0	0	0	62	60
Pre-Treatment COMPLETED	16	15	18	12	63	20	15	62	57
Pre-Treatment NOT COMPLETED	0	0	0	0	0	0	0	0	3
Treatment STARTED	16	15	18	12	63	20	15	62	57
Treatment COMPLETED	11	10	15	9	51	14	11	58	49
Treatment NOT COMPLETED	5	5	3	3	12	6	4	4	8

Reasons for withdrawal

Measure	Part 1: 600 Q4W 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W	Part 2 Arm A: BMS+Nivo+Ipi BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter	Part 2 Arm B: Placebo+Nivo+Ipi Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter
Pre-Treatment Other reasons	0	0	0	0	0	0	0	0	1
Pre-Treatment No longer met study criteria	0	0	0	0	0	0	0	0	1
Pre-Treatment Withdrawal by Subject	0	0	0	0	0	0	0	0	1
Treatment Participant withdrew consent	2	2	0	0	3	3	1	1	1
Treatment Other reasons	0	1	1	0	3	1	2	0	1
Treatment Lost to Follow-up	0	1	0	0	0	0	0	0	0
Treatment Death	3	1	2	3	6	2	1	3	6

Baseline Characteristics

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Baseline characteristics by cohort

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=63 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=20 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=15 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W	Part 2 Arm A: BMS+Nivo+Ipi n=62 Participants BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter	Part 2 Arm B: Placebo+Nivo+Ipi n=60 Participants Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter	Total n=281 Participants Total of all reporting groups
Age, Continuous	60.4 Years n=5 Participants	64.6 Years n=7 Participants	66.3 Years n=5 Participants	64.4 Years n=4 Participants	63.0 Years n=21 Participants	62.6 Years n=8 Participants	56.6 Years n=8 Participants	62.3 Years n=24 Participants	60.6 Years n=42 Participants	62.2 Years n=42 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	18 Participants n=21 Participants	7 Participants n=8 Participants	5 Participants n=8 Participants	22 Participants n=24 Participants	17 Participants n=42 Participants	88 Participants n=42 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	7 Participants n=4 Participants	45 Participants n=21 Participants	13 Participants n=8 Participants	10 Participants n=8 Participants	40 Participants n=24 Participants	43 Participants n=42 Participants	193 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	8 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants	9 Participants n=4 Participants	40 Participants n=21 Participants	13 Participants n=8 Participants	10 Participants n=8 Participants	42 Participants n=24 Participants	41 Participants n=42 Participants	201 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	19 Participants n=21 Participants	7 Participants n=8 Participants	5 Participants n=8 Participants	20 Participants n=24 Participants	18 Participants n=42 Participants	72 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	7 Participants n=42 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants	11 Participants n=4 Participants	59 Participants n=21 Participants	18 Participants n=8 Participants	13 Participants n=8 Participants	56 Participants n=24 Participants	53 Participants n=42 Participants	256 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	14 Participants n=42 Participants

PRIMARY outcome

Timeframe: From first dose up to 100 days after last dose (up to 65 months)

Population: All treated participants in Part 1

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

This endpoint was prespecified in the protocol to include only participants in Part 1.

Outcome measures

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=63 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=20 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=15 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Number of Participants Experiencing Adverse Events (AEs) - Part 1	16 Participants	14 Participants	18 Participants	12 Participants	60 Participants	20 Participants	15 Participants

PRIMARY outcome

Timeframe: From first dose up to 100 days after last dose (up to 65 months)

Population: All treated participants in Part 1

A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.

This endpoint was prespecified in the protocol to include only participants in Part 1.

Outcome measures

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=63 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=20 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=15 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1	13 Participants	10 Participants	13 Participants	7 Participants	31 Participants	12 Participants	9 Participants

PRIMARY outcome

Timeframe: From first dose up to 100 days after last dose (up to 65 months)

Population: All treated participants in Part 1

Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment, as advised by the Dose Review Team. DLTs will be defined based on the incidence, intensity, and duration of AEs that are possibly related to study treatment. DLTs will include gastrointestinal, hepatic, hematologic, dermatologic, and other AEs.

This endpoint was prespecified in the protocol to include only participants in Part 1.

Outcome measures

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=63 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=20 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=15 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Number of Participants Experiencing Dose Limiting Toxicities (DLTs) - Part 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose up to 100 days after last dose (up to 65 months)

Population: All treated participants in Part 1

Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

This endpoint was prespecified in the protocol to include only participants in Part 1.

Outcome measures

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=63 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=20 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=15 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 1	3 Participants	2 Participants	3 Participants	3 Participants	7 Participants	1 Participants	3 Participants

PRIMARY outcome

Timeframe: From first dose up to 100 days after last dose (up to 65 months)

Population: All treated participants in Part 1

The number of participants who died due to any cause are summarized. This endpoint was prespecified in the protocol to include only participants in Part 1.

Outcome measures

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=63 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=20 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=15 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Number of Participants Who Died - Part 1	14 Participants	15 Participants	17 Participants	10 Participants	53 Participants	13 Participants	8 Participants

PRIMARY outcome

Timeframe: From first dose up to 30 days after last dose (up to 63 months)

Population: All treated participants in Part 1

Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

This endpoint was prespecified in the protocol to include only participants in Part 1.

Outcome measures

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=63 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=20 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=15 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Amylase - Grade 4	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Hemoglobin - Grade 3	2 Participants	1 Participants	2 Participants	2 Participants	7 Participants	3 Participants	3 Participants
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Albumin - Grade 3	0 Participants	0 Participants	3 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Alkaline phosphatase - Grade 3	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants	3 Participants	2 Participants
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Alanine aminotransferase - Grade 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Aspartate aminotransferase - Grade 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Phosphate - Grade 3	0 Participants	1 Participants	2 Participants	0 Participants	3 Participants	1 Participants	0 Participants
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Sodium - Grade 3	0 Participants	2 Participants	1 Participants	0 Participants	5 Participants	1 Participants	2 Participants
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Lipase - Grade 3	1 Participants	1 Participants	2 Participants	1 Participants	3 Participants	0 Participants	2 Participants
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Lipase - Grade 4	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Amylase - Grade 3	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)

Population: All randomized participants in Part 2

Objective Response Rate per blinded independent central review (BICR) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as 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 defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 2.

Outcome measures

Measure	Part 1: 600 Q4W n=62 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=60 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Objective Response Rate (ORR) - Part 2	14.5 Percentage of Participants Interval 6.9 to 25.8	11.7 Percentage of Participants Interval 4.8 to 22.6	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)

Population: All treated participants in Part 1

Objective Response Rate per investigator is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as 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 defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 1.

Outcome measures

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=63 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=20 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=15 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Objective Response Rate (ORR) - Part 1	6.3 Percentage of Participants Interval 0.2 to 30.2	6.7 Percentage of Participants Interval 0.2 to 31.9	16.7 Percentage of Participants Interval 3.6 to 41.4	0 Percentage of Participants Interval 0.0 to 26.5	3.2 Percentage of Participants Interval 0.4 to 11.0	10.0 Percentage of Participants Interval 1.2 to 31.7	13.3 Percentage of Participants Interval 1.7 to 40.5

SECONDARY outcome

Timeframe: From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)

Population: All confirmed responders in Part 1

DOR for a participant with a best overall response (BOR) of CR or PR is defined as the date of first response up to the date of the first objectively documented tumor progression by the investigator per RECIST v1.1 or death, whichever occurs first. Analysis computed using Kaplan-Meier method.

Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm.

This endpoint was prespecified in the protocol to include only participants in Part 1.

Outcome measures

Measure	Part 1: 600 Q4W n=1 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=1 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=3 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=2 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=2 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=2 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Duration of Response (DOR) - Part 1	3.7 Months Interval 3.7 to 3.7	28.9 Months Interval 28.9 to 28.9	44.6 Months Interval 8.4 to 44.6	—	21.09 Months Interval 4.0 to 21.1	3.4 Months Interval 3.4 to 3.4	NA Months Interval 3.7 to 24.0 Median not calculated due to insufficient number of events

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: All treated participants in Part 1 who have evaluable concentration-time data.

Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and before the administration of a second dose.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Outcome measures

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=59 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=18 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=12 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Maximum Concentration (Cmax) - Part 1	142.91 ug/mL Geometric Coefficient of Variation 52.1	352.12 ug/mL Geometric Coefficient of Variation 62.7	779.90 ug/mL Geometric Coefficient of Variation 43.1	325.67 ug/mL Geometric Coefficient of Variation 24.0	919.44 ug/mL Geometric Coefficient of Variation 32.8	1227.67 ug/mL Geometric Coefficient of Variation 23.3	999.60 ug/mL Geometric Coefficient of Variation 29.4

SECONDARY outcome

Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Cycle 1 Day 1

Population: All treated participants in Part 1 who have evaluable concentration-time data

AUC (0-T) represents the observed exposure to a drug (area under the concentration curve) from first exposure until the last quantifiable concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Outcome measures

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=59 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=18 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=12 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
AUC(0-T)-Area Under Curve From Time Zero up to Last Quantifiable Concentration - Part 1	19594.22 h*ug/mL Geometric Coefficient of Variation 52.7	44821.39 h*ug/mL Geometric Coefficient of Variation 44.5	105171.46 h*ug/mL Geometric Coefficient of Variation 29.7	42835.41 h*ug/mL Geometric Coefficient of Variation 28.1	112123.35 h*ug/mL Geometric Coefficient of Variation 34.2	148321.77 h*ug/mL Geometric Coefficient of Variation 32.0	118041.10 h*ug/mL Geometric Coefficient of Variation 40.3

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: All treated participants in Part 1 who have evaluable concentration-time data

Area under the concentration-time curve in 1 dosing interval. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Outcome measures

Measure	Part 1: 600 Q4W n=15 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=14 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=56 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=16 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=9 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
AUC(TAU)-Area Under Curve in 1 Dosing Interval - Part 1	21301.74 h*ug/mL Geometric Coefficient of Variation 49.5	48664.06 h*ug/mL Geometric Coefficient of Variation 42.9	106916.11 h*ug/mL Geometric Coefficient of Variation 27.3	43844.97 h*ug/mL Geometric Coefficient of Variation 24.8	113969.47 h*ug/mL Geometric Coefficient of Variation 30.8	153791.84 h*ug/mL Geometric Coefficient of Variation 27.9	137809.44 h*ug/mL Geometric Coefficient of Variation 29.5

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: All treated participants in Part 1 who have evaluable concentration-time data

BMS-986253 observed serum concentration at the end of a dosing interval (Ctau). Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except Cycles 1 and 2 (1 cycle=42 days) in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group

Outcome measures

Measure	Part 1: 600 Q4W n=15 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=14 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=56 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=16 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=9 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Observed Serum Concentration at the End of a Dosing Interval (Ctau) - Part 1	6.81 ug/mL Geometric Coefficient of Variation 173.8	14.92 ug/mL Geometric Coefficient of Variation 144.4	23.68 ug/mL Geometric Coefficient of Variation 692.4	55.82 ug/mL Geometric Coefficient of Variation 53.0	141.89 ug/mL Geometric Coefficient of Variation 42.6	181.84 ug/mL Geometric Coefficient of Variation 46.3	175.29 ug/mL Geometric Coefficient of Variation 46.6

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: All treated participants in Part 1 who have evaluable concentration-time data

Clearance is the rate of elimination of BMS-986253 from the blood calculated as the rate of elimination divided by serum concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Outcome measures

Measure	Part 1: 600 Q4W n=15 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=14 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=56 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=16 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=9 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Total Body Clearance (CLT) - Part 1	28.17 mL/h Geometric Coefficient of Variation 49.5	24.66 mL/h Geometric Coefficient of Variation 42.9	22.45 mL/h Geometric Coefficient of Variation 27.3	27.37 mL/h Geometric Coefficient of Variation 24.8	21.06 mL/h Geometric Coefficient of Variation 30.8	23.41 mL/h Geometric Coefficient of Variation 27.9	26.12 mL/h Geometric Coefficient of Variation 29.5

SECONDARY outcome

Timeframe: Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1

Population: All treated participants in Part 1 who have evaluable concentration-time data

BMS-986253 Average concentration over a dosing interval (\[AUC(TAU)/tau\] (Css-avg) at steady state. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.

Outcome measures

Measure	Part 1: 600 Q4W n=4 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=4 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=8 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=8 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=47 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=13 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=5 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Average Serum Concentration Over a Dosing Interval (Css-avg) - Part 1 C2D1	—	—	—	182.48 ug/mL Geometric Coefficient of Variation 26.6	487.85 ug/mL Geometric Coefficient of Variation 32.4	658.06 ug/mL Geometric Coefficient of Variation 26.2	397.96 ug/mL Geometric Coefficient of Variation 32.7
Average Serum Concentration Over a Dosing Interval (Css-avg) - Part 1 C3D1	59.03 ug/mL Geometric Coefficient of Variation 47.1	66.87 ug/mL Geometric Coefficient of Variation 74.2	181.94 ug/mL Geometric Coefficient of Variation 19.0	—	—	—	—
Average Serum Concentration Over a Dosing Interval (Css-avg) - Part 1 C4D1	—	115.89 ug/mL	—	238.51 ug/mL Geometric Coefficient of Variation 20.1	535.44 ug/mL Geometric Coefficient of Variation 37.4	590.45 ug/mL Geometric Coefficient of Variation 37.5	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1

Population: All treated participants in Part 1 who have evaluable concentration-time data

AUC Accumulation Index is defined as the ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.

Outcome measures

Measure	Part 1: 600 Q4W n=4 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=4 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=8 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=8 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=44 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=10 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=4 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
AUC Accumulation Index (AI_AUC) - Part 1 C2D1	—	—	—	1.45 Ratio Geometric Coefficient of Variation 10.3	1.40 Ratio Geometric Coefficient of Variation 22.8	1.34 Ratio Geometric Coefficient of Variation 20.6	1.19 Ratio Geometric Coefficient of Variation 6.6
AUC Accumulation Index (AI_AUC) - Part 1 C3D1	1.47 Ratio Geometric Coefficient of Variation 37.4	1.07 Ratio Geometric Coefficient of Variation 16.8	1.08 Ratio Geometric Coefficient of Variation 15.7	—	—	—	—
AUC Accumulation Index (AI_AUC) - Part 1 C4D1	—	1.30 Ratio	—	1.77 Ratio Geometric Coefficient of Variation 20.0	1.64 Ratio Geometric Coefficient of Variation 17.2	1.43 Ratio Geometric Coefficient of Variation 7.1	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1

Population: All treated participants in Part 1 who have evaluable concentration-time data

BMS-986253 Cmax accumulation index (AI_Cmax). Ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.

Outcome measures

Measure	Part 1: 600 Q4W n=5 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=5 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=9 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=11 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=51 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=14 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=7 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Cmax Accumulation Index (AI_Cmax) - Part 1 C2D1	—	—	—	1.15 Ratio Geometric Coefficient of Variation 16.7	1.11 Ratio Geometric Coefficient of Variation 36.5	1.21 Ratio Geometric Coefficient of Variation 18.6	1.15 Ratio Geometric Coefficient of Variation 28.3
Cmax Accumulation Index (AI_Cmax) - Part 1 C3D1	0.90 Ratio Geometric Coefficient of Variation 81.6	1.05 Ratio Geometric Coefficient of Variation 16.9	0.86 Ratio Geometric Coefficient of Variation 35.5	—	—	—	—
Cmax Accumulation Index (AI_Cmax) - Part 1 C4D1	1.58 Ratio	1.19 Ratio	—	1.63 Ratio Geometric Coefficient of Variation 46.0	1.36 Ratio Geometric Coefficient of Variation 26.3	0.98 Ratio Geometric Coefficient of Variation 30.9	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1

Population: All treated participants in Part 1 who have evaluable concentration-time data

Ctau is the observed serum concentration at the end of a dosing interval. Ctau accumulation index (AI_Ctau) is the ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint. Ctau was reported on non-compartmental analysis day, which is on Cycle 1 Day1, Cycle 2 Day 1, Cycle 3 Day 1, or Cycle 4 Day 1 based on data available.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.

Outcome measures

Measure	Part 1: 600 Q4W n=4 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=4 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=8 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=8 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=44 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=10 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=4 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Ctau Accumulation Index (AI_Ctau) - Part 1 C2D1	—	—	—	1.90 Ratio Geometric Coefficient of Variation 22.7	1.51 Ratio Geometric Coefficient of Variation 38.0	1.39 Ratio Geometric Coefficient of Variation 30.7	1.10 Ratio Geometric Coefficient of Variation 21.2
Ctau Accumulation Index (AI_Ctau) - Part 1 C3D1	1.33 Ratio Geometric Coefficient of Variation 91.0	1.29 Ratio Geometric Coefficient of Variation 6.5	0.90 Ratio Geometric Coefficient of Variation 53.5	—	—	—	—
Ctau Accumulation Index (AI_Ctau) - Part 1 C4D1	—	1.35 Ratio	—	1.97 Ratio Geometric Coefficient of Variation 31.5	2.01 Ratio Geometric Coefficient of Variation 35.5	1.37 Ratio Geometric Coefficient of Variation 45.2	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1

Population: All treated participants in Part 1 who have evaluable concentration-time data

BMS-986253 effective elimination (T-HALFeff) that explains the degree of accumulation observed for a specific exposure measure. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.

Outcome measures

Measure	Part 1: 600 Q4W n=4 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=3 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=6 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=8 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=41 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=9 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=4 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Effective Elimination (T-HALFeff) - Part 1 C2D1	—	—	—	200.10 Hours Standard Deviation 39.12	202.89 Hours Standard Deviation 76.38	185.51 Hours Standard Deviation 71.51	145.15 Hours Standard Deviation 51.41
Effective Elimination (T-HALFeff) - Part 1 C3D1	410.31 Hours Standard Deviation 275.42	222.95 Hours Standard Deviation 92.65	240.94 Hours Standard Deviation 92.57	—	—	—	—
Effective Elimination (T-HALFeff) - Part 1 C4D1	—	317.87 Hours	—	283.97 Hours Standard Deviation 84.38	247.68 Hours Standard Deviation 73.44	189.42 Hours Standard Deviation 22.08	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: All treated participants in Part 1 who have evaluable concentration-time data

Tmax is defined as the time it takes for a drug to reach the maximum concentration (Cmax) after administration of a drug.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Outcome measures

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=59 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=18 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=12 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Time to Maximum Concentration (Tmax) - Part 1	3.95 Hours Interval 1.0 to 24.0	1.00 Hours Interval 0.9 to 4.1	3.81 Hours Interval 2.0 to 6.1	4.00 Hours Interval 0.9 to 4.2	4.00 Hours Interval 1.0 to 23.5	2.18 Hours Interval 1.9 to 21.1	1.99 Hours Interval 1.9 to 21.8

SECONDARY outcome

Timeframe: C1D15, C1D29, C2D1, C2D9, C2D15, C3D1, C4D1, C4D15, C5D1, C7D1, C9D1, C10D1, C14D1, C20D1, and C26D1

Population: All treated participants in Part 1 who have evaluable concentration-time data

A serum trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. Serum trough concentrations (Ctrough) of BMS-986253 will be summarized with descriptive statistics by treatment and visit.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: The timepoints listed were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.

Outcome measures

Measure	Part 1: 600 Q4W n=10 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=10 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=15 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=11 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=54 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=16 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=11 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Serum Trough Concentration (Ctrough) - Part 1 C5D1 - Predose	—	34491.0 ng/mL	—	125274.8 ng/mL Geometric Coefficient of Variation 27.4	161340.5 ng/mL Geometric Coefficient of Variation 551.8	312899.5 ng/mL Geometric Coefficient of Variation 65.2	—
Serum Trough Concentration (Ctrough) - Part 1 C7D1 - Predose	29506.0 ng/mL	51155.0 ng/mL	76154.6 ng/mL Geometric Coefficient of Variation 26.5	—	—	—	—
Serum Trough Concentration (Ctrough) - Part 1 C9D1 - Predose	—	—	48706.0 ng/mL	182098.0 ng/mL Geometric Coefficient of Variation 43.0	263195.0 ng/mL Geometric Coefficient of Variation 56.6	281410.5 ng/mL Geometric Coefficient of Variation 85.2	—
Serum Trough Concentration (Ctrough) - Part 1 C1D15 - Predose	—	—	—	59518.0 ng/mL Geometric Coefficient of Variation 49.4	149309.4 ng/mL Geometric Coefficient of Variation 37.0	221414.7 ng/mL Geometric Coefficient of Variation 26.0	166358.6 ng/mL Geometric Coefficient of Variation 43.2
Serum Trough Concentration (Ctrough) - Part 1 C26D1 - Predose	—	56040.0 ng/mL	143209.5 ng/mL Geometric Coefficient of Variation 14.8	—	—	—	—
Serum Trough Concentration (Ctrough) - Part 1 C4D15 - Predose	—	—	—	127803.1 ng/mL Geometric Coefficient of Variation 24.5	258413.8 ng/mL Geometric Coefficient of Variation 48.1	356070.0 ng/mL Geometric Coefficient of Variation 56.9	—
Serum Trough Concentration (Ctrough) - Part 1 C4D1 - Predose	27124.2 ng/mL Geometric Coefficient of Variation 99.1	15763.7 ng/mL Geometric Coefficient of Variation 219.2	54841.7 ng/mL Geometric Coefficient of Variation 43.6	86790.7 ng/mL Geometric Coefficient of Variation 41.8	271535.1 ng/mL Geometric Coefficient of Variation 44.9	327146.5 ng/mL Geometric Coefficient of Variation 55.7	145940.5 ng/mL Geometric Coefficient of Variation 19.8
Serum Trough Concentration (Ctrough) - Part 1 C2D1 - Predose	10711.8 ng/mL Geometric Coefficient of Variation 124.6	14450.3 ng/mL Geometric Coefficient of Variation 177.5	45153.8 ng/mL Geometric Coefficient of Variation 50.4	85596.2 ng/mL Geometric Coefficient of Variation 38.1	187079.9 ng/mL Geometric Coefficient of Variation 47.5	272401.3 ng/mL Geometric Coefficient of Variation 54.1	194945.1 ng/mL Geometric Coefficient of Variation 35.3
Serum Trough Concentration (Ctrough) - Part 1 C1D29 - Predose	—	—	—	—	—	—	242843.4 ng/mL Geometric Coefficient of Variation 65.2
Serum Trough Concentration (Ctrough) - Part 1 C2D15 - Predose	—	—	—	98349.7 ng/mL Geometric Coefficient of Variation 46.0	226385.2 ng/mL Geometric Coefficient of Variation 44.5	299360.3 ng/mL Geometric Coefficient of Variation 44.3	112012.1 ng/mL Geometric Coefficient of Variation 37.6
Serum Trough Concentration (Ctrough) - Part 1 C2D29 - Predose	—	—	—	—	—	—	160198.5 ng/mL Geometric Coefficient of Variation 38.2
Serum Trough Concentration (Ctrough) - Part 1 C3D1 - Predose	12124.7 ng/mL Geometric Coefficient of Variation 82.5	21260.6 ng/mL Geometric Coefficient of Variation 131.9	58149.8 ng/mL Geometric Coefficient of Variation 31.5	92359.7 ng/mL Geometric Coefficient of Variation 35.7	224533.3 ng/mL Geometric Coefficient of Variation 54.9	260971.3 ng/mL Geometric Coefficient of Variation 63.9	113514.3 ng/mL Geometric Coefficient of Variation 12.4
Serum Trough Concentration (Ctrough) - Part 1 C10D1 - Predose	—	—	94273.0 ng/mL	—	—	—	—
Serum Trough Concentration (Ctrough) - Part 1 C14D1 - Predose	—	95722.0 ng/mL	102905.0 ng/mL	200795.9 ng/mL Geometric Coefficient of Variation 27.5	298491.4 ng/mL Geometric Coefficient of Variation 50.2	361774.6 ng/mL Geometric Coefficient of Variation 41.4	—
Serum Trough Concentration (Ctrough) - Part 1 C20D1 - Predose	—	72607.0 ng/mL	116745.0 ng/mL	81342.0 ng/mL	424725.7 ng/mL Geometric Coefficient of Variation 23.5	427000.0 ng/mL	—

SECONDARY outcome

Timeframe: C1D1, C1D2, C1D8, C1D15, C1D22, C2D1, C2D2, C2D8, C2D15, C3D1, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C9D1, C14D1, C20D1, C26D1, C32D1, C38D1, 30-day follow-up, 100-day follow-up

Population: All treated participants in Part 1 with baseline and at least one post-baseline evaluable ADA assessment

Blood samples were evaluated for development of Anti-Drug Antibody (ADA) by a validated electrochemiluminescent (ECL) immunoassay. Baseline is defined as first dose.

ADA-positive subject: A subject with at least one ADA positive-sample relative to baseline at any time after initiation of treatment.

Persistent Positive (PP): ADA-positive sample at 2 or more consecutive time points, where the first and last ADA-positive samples are at least 16 weeks apart

Not PP-Last Sample Positive: Not persistent positive with ADA-positive sample at the last sampling time point

Other Positive: Not persistent positive but some ADA-positive samples with the last sample being negative

Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected

ADA-negative subject: A subject with no ADA-positive sample after the initiation of treatment.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Outcome measures

Measure	Part 1: 600 Q4W n=15 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=11 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=16 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=11 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=54 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=15 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=8 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Number of Participants With Anti-Drug Antibodies (ADA) - Part 1 Baseline ADA positive	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Anti-Drug Antibodies (ADA) - Part 1 ADA Positive-Overall	3 Participants	2 Participants	4 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Anti-Drug Antibodies (ADA) - Part 1 ADA Persistent Positive (PP)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-Drug Antibodies (ADA) - Part 1 ADA Positive-Not PP last sample positive	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Anti-Drug Antibodies (ADA) - Part 1 ADA Positive-other positive	1 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Anti-Drug Antibodies (ADA) - Part 1 ADA Negative	12 Participants	9 Participants	12 Participants	11 Participants	52 Participants	15 Participants	7 Participants

SECONDARY outcome

Timeframe: C1D2, C1D8, C1D15, C1D22, C1D29, C1D36, C2D1, C2D2, C2D8, C2D15, C2D22, C2D29, C3D1, C3D2, C3D8, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C7D1, C8D1, C9D1, C10D1, C11D1, C14D1, C16D1, C17D1, C20D1, C23D1, C26D1, at last dose, and 100 days post last dose

Population: All treated participants in Part 1 with available biomarker data

Change from baseline in IL-8 measured in pg/mL. Baseline is defined as first dose.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: Some timepoints were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.

Outcome measures

Measure	Part 1: 600 Q4W n=16 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=13 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=17 Participants 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 Participants 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=61 Participants 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=19 Participants 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=12 Participants 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 2 Day 15	-22.6 pg/mL Interval -99.0 to -3.0	-13.8 pg/mL Interval -30.8 to 3.0	-30.0 pg/mL Interval -70.0 to 6.8	-31.0 pg/mL Interval -63.0 to -17.4	-70.8 pg/mL Interval -1569.1 to 3.1	-74.6 pg/mL Interval -501.3 to -7.4	9.1 pg/mL Interval -22.2 to 56.0
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 4 Day 1	-30.3 pg/mL Interval -101.0 to 18.0	-8.8 pg/mL Interval -26.0 to 13.0	-15.5 pg/mL Interval -28.4 to 3.5	-18.5 pg/mL Interval -38.9 to 1.0	-102.9 pg/mL Interval -1568.8 to 2.0	-29.6 pg/mL Interval -86.0 to 9.0	-23.8 pg/mL Interval -26.4 to -21.1
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 8 Day 1	—	—	-21.8 pg/mL Interval -21.8 to -21.8	—	—	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 9 Day 1	—	—	-17.0 pg/mL Interval -17.0 to -17.0	-28.2 pg/mL Interval -38.5 to -18.6	-27.8 pg/mL Interval -48.3 to -13.6	-9.1 pg/mL Interval -11.0 to -7.1	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Follow-up 1	—	—	17.5 pg/mL Interval 9.0 to 26.0	—	—	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 1 Day 2	-96.9 pg/mL Interval -891.0 to -24.3	-37.3 pg/mL Interval -105.6 to -7.0	-66.3 pg/mL Interval -377.0 to -5.8	-48.2 pg/mL Interval -115.5 to -21.6	-48.5 pg/mL Interval -141.5 to -4.4	-82.8 pg/mL Interval -509.6 to -8.2	-76.1 pg/mL Interval -268.2 to -18.6
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 1 Day 8	-78.2 pg/mL Interval -857.0 to -5.0	-31.4 pg/mL Interval -94.0 to -6.2	-58.6 pg/mL Interval -350.0 to -4.8	-40.3 pg/mL Interval -107.0 to -17.2	-69.8 pg/mL Interval -1569.6 to 2.2	-48.1 pg/mL Interval -121.0 to -5.0	-71.9 pg/mL Interval -246.0 to -6.0
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 1 Day 15	-66.2 pg/mL Interval -769.0 to 11.0	-24.4 pg/mL Interval -79.0 to 3.0	-34.3 pg/mL Interval -87.0 to -0.3	-23.6 pg/mL Interval -63.0 to -11.0	-38.0 pg/mL Interval -123.2 to 89.0	-65.8 pg/mL Interval -502.5 to -1.0	-33.5 pg/mL Interval -120.0 to -3.0
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 1 Day 22	-48.0 pg/mL Interval -561.0 to 24.0	17.4 pg/mL Interval -30.8 to 277.0	-41.6 pg/mL Interval -240.0 to 11.8	-33.0 pg/mL Interval -77.0 to -18.6	-71.3 pg/mL Interval -1559.0 to 1.7	-68.1 pg/mL Interval -507.2 to -8.2	-34.3 pg/mL Interval -104.0 to -6.0
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 1 Day 29	—	—	—	—	—	—	-23.2 pg/mL Interval -62.9 to -4.0
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 1 Day 36	—	—	—	—	—	—	-29.1 pg/mL Interval -66.8 to -10.2
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 2 Day 1	3.8 pg/mL Interval -67.0 to 50.0	43.5 pg/mL Interval -28.0 to 427.0	-20.3 pg/mL Interval -73.0 to 32.8	-25.3 pg/mL Interval -58.0 to -5.0	-40.2 pg/mL Interval -127.8 to 4.0	-78.3 pg/mL Interval -506.1 to -9.0	-21.3 pg/mL Interval -65.5 to 23.0
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 2 Day 2	—	—	—	-42.5 pg/mL Interval -84.0 to -21.6	-47.3 pg/mL Interval -139.4 to 0.0	-48.2 pg/mL Interval -127.1 to -8.2	-31.5 pg/mL Interval -68.6 to -7.7
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 2 Day 8	—	—	—	-35.6 pg/mL Interval -77.0 to -18.6	-44.2 pg/mL Interval -136.8 to 0.6	-77.4 pg/mL Interval -508.2 to -8.2	-26.1 pg/mL Interval -68.0 to -5.5
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 2 Day 22	—	—	—	—	—	—	-18.7 pg/mL Interval -29.4 to -2.8
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 2 Day 29	—	—	—	—	—	—	-22.7 pg/mL Interval -26.9 to -18.0
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 3 Day 1	2.0 pg/mL Interval -82.0 to 44.0	-4.0 pg/mL Interval -25.0 to 30.0	-16.4 pg/mL Interval -49.0 to 21.0	-25.1 pg/mL Interval -38.0 to -8.0	-86.7 pg/mL Interval -1569.6 to 2.3	-93.5 pg/mL Interval -508.2 to -8.1	-14.4 pg/mL Interval -21.0 to 4.0
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 3 Day 2	—	—	—	—	-24.9 pg/mL Interval -24.9 to -24.9	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 3 Day 8	-36.3 pg/mL Interval -113.0 to -7.0	-24.5 pg/mL Interval -34.5 to -15.0	-37.0 pg/mL Interval -77.0 to -13.2	—	—	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 3 Day 15	-44.3 pg/mL Interval -117.0 to -2.0	-20.8 pg/mL Interval -31.7 to -14.0	-24.3 pg/mL Interval -46.8 to -5.0	—	—	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 3 Day 22	-53.5 pg/mL Interval -107.0 to 0.0	-15.4 pg/mL Interval -27.0 to -2.0	-16.9 pg/mL Interval -43.0 to 23.0	—	—	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 4 Day 2	—	-35.7 pg/mL Interval -35.7 to -35.7	—	-32.0 pg/mL Interval -41.7 to -21.3	-33.5 pg/mL Interval -81.6 to 0.5	-44.0 pg/mL Interval -96.9 to -13.6	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 4 Day 8	—	-32.1 pg/mL Interval -32.1 to -32.1	—	-30.3 pg/mL Interval -40.9 to -19.6	-32.7 pg/mL Interval -81.6 to 3.8	-43.8 pg/mL Interval -92.1 to -8.2	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 4 Day 15	—	-29.0 pg/mL Interval -29.0 to -29.0	—	-26.7 pg/mL Interval -38.6 to -17.6	-34.5 pg/mL Interval -122.5 to 6.0	-46.4 pg/mL Interval -90.6 to -8.2	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 4 Day 22	—	-26.0 pg/mL Interval -26.0 to -26.0	—	-28.8 pg/mL Interval -38.5 to -19.1	-30.6 pg/mL Interval -81.1 to 2.7	-43.8 pg/mL Interval -94.5 to -7.6	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 5 Day 1	38.0 pg/mL Interval 38.0 to 38.0	—	—	-27.3 pg/mL Interval -36.0 to -17.7	-28.2 pg/mL Interval -80.3 to 4.9	-46.8 pg/mL Interval -91.7 to -8.2	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 7 Day 1	-111.0 pg/mL Interval -111.0 to -111.0	-8.0 pg/mL Interval -25.0 to 9.0	-14.6 pg/mL Interval -29.7 to -1.7	-29.3 pg/mL Interval -38.5 to -20.0	-33.0 pg/mL Interval -80.8 to -13.6	-36.9 pg/mL Interval -86.6 to -8.2	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 10 Day 1	—	—	-14.2 pg/mL Interval -32.3 to 0.7	—	—	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 11 Day 1	—	-16.0 pg/mL Interval -28.0 to -4.0	—	-30.7 pg/mL Interval -37.7 to -21.4	-24.4 pg/mL Interval -39.5 to -13.6	-7.6 pg/mL Interval -7.6 to -7.6	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 14 Day 1	—	-16.1 pg/mL Interval -36.2 to 4.0	-2.2 pg/mL Interval -2.2 to -2.2	-1.6 pg/mL Interval -36.8 to 48.0	-22.2 pg/mL Interval -38.2 to -13.6	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 16 Day 1	—	—	-1.6 pg/mL Interval -1.6 to -1.6	—	—	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 17 Day 1	—	-32.2 pg/mL Interval -32.2 to -32.2	-17.3 pg/mL Interval -30.5 to -4.1	-38.0 pg/mL Interval -38.0 to -38.0	-14.2 pg/mL Interval -14.8 to -13.6	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 20 Day 1	—	-30.7 pg/mL Interval -30.7 to -30.7	-32.5 pg/mL Interval -32.5 to -32.5	-34.4 pg/mL Interval -34.4 to -34.4	-17.1 pg/mL Interval -23.6 to -13.6	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 23 Day 1	—	-28.9 pg/mL Interval -28.9 to -28.9	-27.1 pg/mL Interval -32.2 to -22.0	—	-22.6 pg/mL Interval -22.6 to -22.6	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 Cycle 26 Day 1	—	-30.8 pg/mL Interval -30.8 to -30.8	-10.0 pg/mL Interval -22.6 to 2.5	—	—	—	—
Change From Baseline in Interleukin 8 (IL-8)- Part 1 End of Treatment	-44.0 pg/mL Interval -105.0 to 17.0	—	-49.5 pg/mL Interval -66.0 to -29.0	-24.6 pg/mL Interval -37.0 to -10.0	-34.5 pg/mL Interval -125.0 to 20.0	-149.1 pg/mL Interval -503.2 to -16.0	-50.9 pg/mL Interval -65.0 to -36.8

SECONDARY outcome

Timeframe: From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)

Population: All randomized participants in Part 2

Progression free survival (PFS) is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.

Progressive Disease (PD): 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. The appearance of one or more new lesions is also considered progression.

This endpoint was prespecified in the protocol to include only participants in Part 2.

Outcome measures

Measure	Part 1: 600 Q4W n=62 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=60 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Progression Free Survival (PFS) - Part 2	2.103 Months Interval 1.873 to 3.778	3.318 Months Interval 1.906 to 3.745	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose up to 100 days after last dose (up to 25 months)

Population: All treated participants in Part 2

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

This endpoint was prespecified in the protocol to include only participants in Part 2.

Outcome measures

Measure	Part 1: 600 Q4W n=62 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=57 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Number of Participants Experiencing Adverse Events (AEs) - Part 2	62 Participants	56 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose up to 100 days after last dose (up to 25 months)

Population: All treated participants in Part 2

A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.

Outcome measures

Measure	Part 1: 600 Q4W n=62 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=57 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 2	44 Participants	42 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose up to 100 days after last dose (up to 25 months)

Population: All treated participants in Part 2

Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Outcome measures

Measure	Part 1: 600 Q4W n=62 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=57 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 2	16 Participants	23 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose up to 100 days after last dose (up to 25 months)

Population: All treated participants in Part 2

The number of participants who died due to any cause are summarized.

Outcome measures

Measure	Part 1: 600 Q4W n=62 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=57 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Number of Participants Who Died - Part 2	30 Participants	17 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose up to 30 days after last dose (up to 23 months)

Population: All treated participants in Part 2

Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

This endpoint was prespecified in the protocol to include only participants in Part 2.

Outcome measures

Measure	Part 1: 600 Q4W n=62 Participants 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=57 Participants 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2 Sodium - Grade 3	6 Participants	8 Participants	—	—	—	—	—
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2 Sodium - Grade 4	2 Participants	0 Participants	—	—	—	—	—
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2 Lipase - Grade 3	4 Participants	5 Participants	—	—	—	—	—
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2 Lipase - Grade 4	5 Participants	5 Participants	—	—	—	—	—
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2 Amylase - Grade 3	3 Participants	4 Participants	—	—	—	—	—
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2 Alanine aminotransferase - Grade 3	4 Participants	6 Participants	—	—	—	—	—
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2 Alanine aminotransferase - Grade 4	2 Participants	1 Participants	—	—	—	—	—
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2 Aspartate aminotransferase - Grade 3	3 Participants	3 Participants	—	—	—	—	—
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2 Aspartate aminotransferase - Grade 4	1 Participants	0 Participants	—	—	—	—	—
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2 Phosphate - Grade 3	3 Participants	3 Participants	—	—	—	—	—

Adverse Events

Part 1: 600 Q4W

Serious events: 13 serious events

Other events: 16 other events

Deaths: 14 deaths

Part 1: 1200 Q4W

Serious events: 10 serious events

Other events: 14 other events

Deaths: 15 deaths

Part 1: 2400 Q4W

Serious events: 13 serious events

Other events: 18 other events

Deaths: 17 deaths

Part 1: 1200 Q2W

Serious events: 7 serious events

Other events: 11 other events

Deaths: 10 deaths

Part 1: 2400 Q2W

Serious events: 31 serious events

Other events: 59 other events

Deaths: 53 deaths

Part 1: 3600 Q2W

Serious events: 12 serious events

Other events: 19 other events

Deaths: 13 deaths

Part 1: 3600Q2W + Nivo + Ipi

Serious events: 9 serious events

Other events: 15 other events

Deaths: 8 deaths

Part 2 Arm A: BMS+Nivo+Ipi

Serious events: 44 serious events

Other events: 61 other events

Deaths: 30 deaths

Part 2 Arm B: Placebo+Nivo+Ipi

Serious events: 42 serious events

Other events: 54 other events

Deaths: 17 deaths

Serious adverse events

Measure	Part 1: 600 Q4W n=16 participants at risk 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 participants at risk 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 participants at risk 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 participants at risk 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=63 participants at risk 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=20 participants at risk 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=15 participants at risk 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W	Part 2 Arm A: BMS+Nivo+Ipi n=62 participants at risk BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter	Part 2 Arm B: Placebo+Nivo+Ipi n=57 participants at risk Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter
Blood and lymphatic system disorders Anaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Blood and lymphatic system disorders Pancytopenia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Acute coronary syndrome	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Cardiac arrest	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Cardiac failure congestive	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Myocarditis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Pericardial effusion	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Endocrine disorders Adrenal haemorrhage	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Endocrine disorders Glucocorticoid deficiency	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Endocrine disorders Hypophysitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Endocrine disorders Hypopituitarism	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Abdominal pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Ascites	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Colitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.5% 4/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	12.3% 7/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Colonic fistula	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Constipation	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Diarrhoea	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.5% 4/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.0% 4/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Dysphagia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Enterocolitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Gastritis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Haemorrhoids	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Ileus	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Nausea	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Rectal prolapse	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Retroperitoneal disorder	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Erysipelas	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Upper gastrointestinal haemorrhage	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Vomiting	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Asthenia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Cardiac death	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Death	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.5% 4/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Fatigue	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders General physical health deterioration	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Non-cardiac chest pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Pyrexia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Cholangitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Cholecystitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Hepatic failure	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Hepatitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Bacillus infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Bacteraemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Bronchitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Enterocolitis infectious	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Gastroenteritis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Influenza	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Kidney infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Lymph gland infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Mastitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Peritonitis bacterial	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Pneumonia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	9.5% 6/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Pneumonia aspiration	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Porphyromonas bacteraemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Pyelonephritis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Sepsis	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Staphylococcal infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Upper respiratory tract infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Urinary tract infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Urinary tract infection enterococcal	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Vascular device infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Wound infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Alanine aminotransferase increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Aspartate aminotransferase increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood bilirubin increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood creatinine increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations General physical condition abnormal	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Troponin T increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Decreased appetite	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Dehydration	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.1% 5/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Steroid diabetes	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	31.2% 5/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	44.4% 8/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	41.7% 5/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	27.0% 17/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	30.0% 6/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	9.7% 6/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	17.5% 10/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Ataxia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Axonal neuropathy	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Carotid blowout syndrome	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Cerebral haemorrhage	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Cerebrovascular accident	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Diabetic coma	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Guillain-Barre syndrome	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Haemorrhage intracranial	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Hemiparesis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Hepatic encephalopathy	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Middle cerebral artery stroke	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Neuropathy peripheral	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Transient ischaemic attack	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Product Issues Device occlusion	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Psychiatric disorders Confusional state	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Psychiatric disorders Mental status changes	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Acute kidney injury	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Immune-mediated nephritis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Renal failure	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Urinary tract obstruction	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 2/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.3% 4/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Aortic aneurysm	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Aortic stenosis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Haematoma	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Hypotension	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Superior vena cava syndrome	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment

Other adverse events

Measure	Part 1: 600 Q4W n=16 participants at risk 600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q4W n=15 participants at risk 1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 2400 Q4W n=18 participants at risk 2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W	Part 1: 1200 Q2W n=12 participants at risk 1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 2400 Q2W n=63 participants at risk 2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600 Q2W n=20 participants at risk 3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W	Part 1: 3600Q2W + Nivo + Ipi n=15 participants at risk 3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W	Part 2 Arm A: BMS+Nivo+Ipi n=62 participants at risk BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter	Part 2 Arm B: Placebo+Nivo+Ipi n=57 participants at risk Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter
Blood and lymphatic system disorders Leukocytosis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Blood and lymphatic system disorders Anaemia	18.8% 3/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	27.8% 5/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 2/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	25.4% 16/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	35.0% 7/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	40.0% 6/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	33.9% 21/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	24.6% 14/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Blood and lymphatic system disorders Lymphopenia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	12.9% 8/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Blood and lymphatic system disorders Neutrophilia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Aortic valve incompetence	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Atrial fibrillation	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Bundle branch block bilateral	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Cardiac failure congestive	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Palpitations	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Sinus tachycardia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Cardiac disorders Tachycardia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	22.2% 4/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Ear and labyrinth disorders Deafness	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Ear and labyrinth disorders Ear discomfort	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Endocrine disorders Adrenal insufficiency	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Endocrine disorders Hyperthyroidism	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Endocrine disorders Hypothyroidism	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Eye disorders Lacrimation increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Eye disorders Vision blurred	12.5% 2/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Abdominal discomfort	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Abdominal distension	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.5% 4/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.0% 4/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.3% 9/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.5% 9/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.8% 9/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Abdominal pain lower	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Abdominal pain upper	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	9.7% 6/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Anorectal discomfort	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Ascites	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Colitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.1% 5/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.5% 6/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Constipation	18.8% 3/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	33.3% 5/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	22.2% 4/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.3% 9/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	25.0% 5/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	21.0% 13/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	21.1% 12/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Diarrhoea	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 2/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	22.2% 14/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	30.0% 6/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	33.3% 5/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	43.5% 27/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	43.9% 25/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Dry mouth	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.0% 4/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Hepatitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.1% 5/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Dyspepsia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Dysphagia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Epigastric discomfort	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Flatulence	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Gastritis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Gastrointestinal fistula	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Gastrointestinal wall thickening	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.9% 5/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.0% 4/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Haematemesis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Haematochezia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Ileus	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Mucous stools	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Nausea	18.8% 3/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	33.3% 5/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	22.2% 4/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	33.3% 4/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	23.8% 15/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	25.0% 5/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	32.3% 20/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	31.6% 18/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Odynophagia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Stomatitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Tongue ulceration	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Gastrointestinal disorders Vomiting	12.5% 2/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	9.5% 6/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.3% 7/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.8% 9/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Asthenia	12.5% 2/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 2/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.3% 9/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	29.0% 18/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.8% 5/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Axillary pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Chest discomfort	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Chest pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Chills	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.3% 4/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.8% 5/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Face oedema	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Fatigue	37.5% 6/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	40.0% 6/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	33.3% 6/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	25.0% 3/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	36.5% 23/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	45.0% 9/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	24.2% 15/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	38.6% 22/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders General physical health deterioration	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Generalised oedema	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Influenza like illness	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Injection site extravasation	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Localised oedema	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Malaise	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Medical device pain	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Non-cardiac chest pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Oedema peripheral	18.8% 3/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 4/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.5% 4/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.8% 9/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Peripheral swelling	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
General disorders Pyrexia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	17.5% 11/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	25.0% 5/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	35.5% 22/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	28.1% 16/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Hepatic failure	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Immune system disorders Cytokine release syndrome	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Immune system disorders Seasonal allergy	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Bronchitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.5% 4/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations COVID-19	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.1% 5/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Carbuncle	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Conjunctivitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Cystitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Herpes zoster	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Herpes zoster reactivation	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Hordeolum	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Influenza	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Kidney infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Oral candidiasis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Paronychia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Peritonitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Pneumonia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.3% 4/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.5% 4/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Pneumonia pseudomonal	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Postoperative wound infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Respiratory tract infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Rhinovirus infection	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Sialoadenitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Stoma site infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Tooth infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Upper respiratory tract infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Urinary tract infection	25.0% 4/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 7/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Infections and infestations Wound infection	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Injury, poisoning and procedural complications Fall	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Injury, poisoning and procedural complications Head injury	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Injury, poisoning and procedural complications Procedural pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Injury, poisoning and procedural complications Wound	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Injury, poisoning and procedural complications Wound secretion	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Alanine aminotransferase increased	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 4/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	29.0% 18/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	22.8% 13/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Amylase increased	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	12.9% 8/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.0% 4/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Aspartate aminotransferase increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	24.2% 15/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.0% 8/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood albumin decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.3% 7/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood alkaline phosphatase increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	22.2% 4/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.3% 4/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.5% 4/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.0% 4/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood bilirubin increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	9.7% 6/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood creatine phosphokinase increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood creatinine increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 2/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.0% 4/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood folate decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood iron decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood lactate dehydrogenase increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.5% 9/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.5% 6/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood magnesium decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.1% 5/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood pH decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood testosterone decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood urea increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.1% 5/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Blood uric acid increased	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Gamma-glutamyltransferase increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	17.7% 11/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.5% 6/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Lipase increased	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	17.7% 11/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	12.3% 7/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Lymphocyte count decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.5% 4/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Neutrophil count decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Platelet count decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.5% 4/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Platelet count increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Protein total decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	12.9% 8/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.0% 4/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Transaminases increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Weight decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 7/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	25.0% 5/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.0% 4/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations Weight increased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Investigations White blood cell count decreased	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Decreased appetite	31.2% 5/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	22.2% 4/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	33.3% 21/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	19.4% 12/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	21.1% 12/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Dehydration	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Fluid retention	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 7/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	21.0% 13/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	12.3% 7/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hyperkalaemia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	27.8% 5/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.3% 4/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypocalcaemia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	12.9% 8/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.1% 5/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hyponatraemia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	22.2% 4/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	9.5% 6/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	12.9% 8/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.5% 6/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.5% 4/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.5% 6/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	9.7% 6/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Iron deficiency	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.9% 10/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.5% 9/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	21.1% 12/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Back pain	12.5% 2/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 7/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	9.7% 6/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	12.3% 7/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Muscular weakness	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	9.7% 6/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	12.3% 7/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	12.7% 8/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.3% 7/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Amnesia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Aphasia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Central nervous system lesion	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Cerebrovascular accident	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Dizziness	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.8% 5/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Dysarthria	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Dysgeusia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.0% 4/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Headache	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	17.7% 11/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	19.3% 11/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Hypoaesthesia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Urogenital haemorrhage	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Hypokinesia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Lethargy	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Migraine	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Neuropathy peripheral	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Paraesthesia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Presyncope	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Somnolence	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Syncope	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Nervous system disorders Tremor	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Psychiatric disorders Agitation	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Psychiatric disorders Anxiety	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Psychiatric disorders Confusional state	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Psychiatric disorders Depression	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Psychiatric disorders Dysphoria	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Psychiatric disorders Hallucination	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Psychiatric disorders Insomnia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 7/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.5% 9/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.0% 8/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Psychiatric disorders Personality change	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Psychiatric disorders Poor quality sleep	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Acute kidney injury	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Haematuria	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.9% 5/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Hydronephrosis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Nocturia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Pollakiuria	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Proteinuria	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	22.2% 4/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Renal and urinary disorders Urinary retention	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Reproductive system and breast disorders Scrotal oedema	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Reproductive system and breast disorders Scrotal pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.9% 10/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	21.0% 13/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.0% 8/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea	31.2% 5/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	33.3% 5/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	25.0% 3/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.3% 9/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	14.5% 9/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.5% 6/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Hypoxia	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	15.0% 3/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.1% 2/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.7% 3/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Rhonchi	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Sinus pain	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.3% 4/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Eczema	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Erythema	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Nail bed bleeding	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	19.0% 12/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	29.0% 18/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	31.6% 18/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Rash	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	7.9% 5/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	16.1% 10/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	17.5% 10/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	11.3% 7/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	19.3% 11/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Skin ulcer	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.1% 5/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Embolism	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Flushing	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Haematoma	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.0% 1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Hot flush	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.8% 1/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Hypertension	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	22.2% 4/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	4.8% 3/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Hypotension	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.6% 1/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	8.3% 1/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	10.0% 2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	5.3% 3/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Lymphoedema	0.00% 0/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.2% 2/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	3.5% 2/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Superior vena cava syndrome	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Vascular disorders Thrombosis	6.2% 1/16 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/18 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/12 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/63 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	1.6% 1/62 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment	0.00% 0/57 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months). The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment

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